21 C.F.R. PART 510—NEW ANIMAL DRUGS
Title 21 - Food and Drugs
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
Source: 40 FR 13807, Mar. 27, 1975, unless otherwise noted.
As used in this part: (a) The term act means the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201–902, 52 Stat. 1040 et seq., as amended; 21 U.S.C. 321–392). (b) Department means the Department of Health and Human Services. (c) Secretary means the Secretary of Health and Human Services. (d) Commissioner means the Commissioner of Food and Drugs. (e) Person means individuals, partnerships, corporations, and associations. (f) The definitions and interpretations of terms contained in section 201 of the act shall be applicable to such terms when used in the regulations in this part. (g) The term new animal drug means any drug intended for use for animals other than man, including any drug intended for use in animal feed but not including such animal feed: (1) The composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof; except that such a drug not so recognized shall not be deemed to be a new animal drug if at any time prior to June 25, 1938, it was subject to the Food and Drug Act of June 30, 1906, as amended, and if at such time its labeling contained the same representations concerning the conditions of its use; or (2) The composition of which is such that such drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions. (h) The term animal feed means an article which is intended for use for food for animals other than man and which is intended for use as a substantial source of nutrients in the diet of the animal, and is not limited to a mixture intended to be the sole ration of the animal. (i) The newness of an animal drug, including a new animal drug intended for use in or on animal feed, may arise by reason of: (1) The newness for its intended drug use of any substance of which the drug is comprised, in whole or in part, whether it be an active substance or a menstruum, excipient, carrier, coating, or other component; (2) the newness for its intended drug use of a combination of two or more substances, none of which is itself a new animal drug; (3) the newness for its intended drug use of the proportion of a substance in a combination, even though such combination containing such substance in other proportion is not a new animal drug; (4) the newness for its intended drug use in a different species of animal; (5) the newness of its intended drug use in diagnosing, curing, mitigating, treating, or preventing a disease, or to affect a structure or function of the animal body, even though such drug is not a new animal drug when used in another disease or to affect another structure or function of the body; or (6) the newness of a dosage, or method or duration of administration or application, or any other condition of use prescribed, recommended, or suggested in the labeling of such drug, even though such drug or animal feed containing such drug when used in another dosage, or another method or duration of administration or application, or different condition, is not a new animal drug. (j) Animals used only for laboratory research and laboratory research animals mean individual animals or groups of animals intended for use and used solely for laboratory research purposes, regardless of species, and does not include animals intended to be used for any food purposes or animals intended to be kept as livestock. (k) The term sponsor means the person responsible for an investigation of a new animal drug, including responsibility for compliance with applicable provisions of the act and regulations. The sponsor may be an individual, partnership, corporation, or Government agency or may be a manufacturer, scientific institution, or an investigator regularly and lawfully engaged in the investigation of new animal drugs. [40 FR 13807, Mar. 27, 1975, as amended at 50 FR 7517, Feb. 22, 1985; 54 FR 22741, May 26, 1989; 64 FR 69190, Dec. 10, 1999] An animal drug produced and distributed in full conformance with the animal virus, serum, and toxin law of March 4, 1913 (37 Stat. 832; 21 U.S.C. 151 et seq. ) and any regulations issued thereunder shall not be deemed to be subject to section 512 of the Federal Food, Drug, and Cosmetic Act. (a) A new animal drug intended for use in the manufacture of animal feed shall be deemed to be unsafe unless at the time of its removal from the establishment of a manufacturer, packer, or distributor of such drug, such manufacturer, packer, or distributor has an unrevoked written statement from the consignee of such drug, or a notice from the Secretary, to the effect that with respect to the use of such drug in animal feed the consignee: (1) Holds a license issued under §515.20 of this chapter; or (2) Will, if the consignee is not the user of the drug, ship such drug only to a holder of an approved application under §515.10 of this chapter. (b) The requirements of paragraph (a) of this section do not apply: (1) Where such drugs are intended for export and/or (2) When the use of such drug in the manufacture of a finished feed has been exempted from the requirements of section 512(m) of the act under the conditions specified by regulations published in part 558 of this chapter. [40 FR 13807, Mar. 27, 1975, as amended at 64 FR 63203, Nov. 19, 1999] (a) Part 526 of this chapter provides for new animal drugs intended for intramammary use in animals and includes conditions of use intended to prevent the contamination of milk from the use of such drugs. (b) Preparations containing antibiotics and other potent drugs labeled with directions for use in milk-producing animals will be misbranded under section 502(f)(2) of the act unless their labeling bears appropriate warnings and directions for use to avoid adulteration of milk under section 402(a)(2)(c)(ii) of the act. (c) It is the position of the Food and Drug Administration that the labeling for such preparations should bear a clear warning that either: (1) The article should not be administered to animals producing milk, since to do so would result in contamination of the milk; or (2) The label should bear the following statement: “Warning: Milk that has been taken from animals during treatment and for __ hours after the latest treatment must not be used for food”, the blank being filled in with the figure that the manufacturer has determined by appropriate investigation is needed to insure that the milk will not carry violative residues resulting from use of the preparation. If the use of the preparation as recommended does not result in contamination of the milk, neither of the above warning statements is required. [40 FR 13807, Mar. 27, 1975, as amended at 63 FR 32980, June 17, 1998; 64 FR 51241, Sept. 22, 1999] Whenever the labeling of an antibiotic drug included in the regulations in this chapter suggests or recommends its use in milk-producing animals, the label of such drugs shall bear either the statement “Warning: Not for use in animals producing milk, since this use will result in contamination of the milk” or the statement “Warning: Milk that has been taken from animals during treatment and for __hours after the latest treatment must not be used for food”, the blank being filled in with the figure that the Commissioner has authorized the manufacturer of the drug to use. The Commissioner shall determine what such figures shall be from information submitted by the manufacturer and which the Commissioner considers is adequate to prove that period of time after the latest treatment that the milk from treated animals will contain no violative residues from use of the preparation. If the Commissioner determines from the information submitted that the use of the antibiotic drug as recommended does not result in its appearance in the milk, the Commissioner may exempt the drug from bearing either of the above warning statements. [63 FR 32980, June 17, 1998] (a) The Food and Drug Administration in the interest of fulfilling its responsibilities with regard to protection of the public health has requested an evaluation of the public health aspects of the use of antibiotics in veterinary medical and nonmedical uses. There is particular concern with regard to the potential hazards associated with the extensive use of antibiotics administered to food-producing animals. Accordingly, an ad hoc committee on the Veterinary Medical and Nonmedical Uses of Antibiotics was established by the Food and Drug Administration to study and advise the Commissioner of Food and Drugs on the uses of antibiotics in veterinary medicine and for various nonmedical purposes as such uses may affect the enforcement of the Federal Food, Drug, and Cosmetic Act with respect to their safety and effectiveness. (b) Based upon an evaluation of the conclusions of said Committee and other relevant material, §510.112 was published in the (c) An evaluation of the data now available shows that use of many antibiotic preparations cause residues in edible products of treated animals for varying and, in some cases, for long periods of time following the last administration. Because of the accumulation of new information with regard to the development of resistance of bacteria to antibiotics, the ability of bacteria to transfer this resistance, and the development of sensitivity to antibiotics in humans, unauthorized and unsafe residues of antibiotics cannot be permitted in food obtained from treated animals. (d) Based on evaluation of information available, including the conclusions of the aforementioned ad hoc Committee, the Commissioner concludes that antibiotic preparations intended for use in food-producing animals, other than topical and ophthalmic preparations, are not generally recognized among qualified experts as having been shown to be safe for their intended use(s) within the meaning of section 201(s) of the Federal Food, Drug, and Cosmetic Act. (e) Therefore, all exemptions from the provisions of section 409 of the act for use of antibiotics in food-producing animals based on sanctions or approvals granted prior to enactment of the Food Additives Amendment of 1958 (Pub. L. 85–929; 72 Stat. 1784) will be revoked and the uses which are concluded to be safe will be covered by food additive regulations. On those products for which there are inadequate residue data, actions will be initiated to withdraw approval of new-drug applications under the provisions of section 505 of the act. Antibiotic preparations, other than those for topical and ophthalmic application in food-producing animals, which are not covered by food additive regulations will be subject to regulatory action within 180 days after publication of the forthcoming revocation order. (f) Because of the variation in the period of time that antibiotic residues may remain in edible products from treated animals, all injectable, intramammary infusion, intrauterine, and oral preparations, including medicated premixes intended for use in food-producing animals, are deemed to be new drugs as well as food additives. [40 FR 13807, Mar. 27, 1975, as amended at 54 FR 18280, Apr. 28, 1989; 64 FR 403, Jan. 5, 1999] (a) An ad hoc committee, Committee on the Veterinary Medical and Nonmedical Uses of Antibiotics, was formed by the Food and Drug Administration to study, and advise the Commissioner on, the use of antibiotics in veterinary medicine and for various nonmedical purposes as such uses may affect the enforcement of the Federal Food, Drug, and Cosmetic Act with respect to the safety and effectiveness of such substances. A copy of the report may be obtained from the Food and Drug Administration, Office of Public Affairs, Room 15–05, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. (b) On the basis of the report of the Committee and other information, sponsors of drugs containing any antibiotic intended for use in food-producing animals shall submit data for determining whether or not such antibiotics and their metabolites are present as residues in edible tissues, milk, and eggs from treated animals; however, in the case of a drug for which such data have already been submitted and for which a regulation has been promulgated under section 409 of the act, only such data as has been accumulated since the issuance of the regulation need be submitted. (c) The required data shall be submitted within 180 days of the date of publication of this section in the (d) Regulatory proceedings including revocation of prior sanctions, or actions to suspend or amend new drug or antibiotic approvals granted prior to passage of the Food Additives Amendment of 1958 (72 Stat. 1784), may be initiated with regard to the continued marketing of any antibiotic preparation on which the required information is not submitted within the period of time prescribed by paragraph (c) of this section. (e) Questions relating to the acceptability of proposed research protocols and assay methods for determining the amount of antibiotic residues in food should be directed to the Director, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. [40 FR 13807, Mar. 27, 1975, as amended at 46 FR 8460, Jan. 27, 1981; 54 FR 18280, Apr. 28, 1989; 57 FR 6475, Feb. 25, 1992] Records and reports of clinical and other experience with the new animal drug will be maintained and reported, appropriately identified with the new animal drug application(s) to which they relate, to the Center for Veterinary Medicine in duplicate in accordance with the following: (a) Immediately upon receipt by the applicant, complete records or reports covering information of the following kinds: (1) Information concerning any mixup in the new animal drug or its labeling with another article. (2) Information concerning any bacteriological, or any significant chemical, physical, or other change or deterioration in the drug, or any failure of one or more distributed batches of the drug to meet the specifications established for it in the new animal drug application. (b) As soon as possible, and in any event within 15 working days of its receipt by the applicant, complete records or reports concerning any information of the following kinds: (1) Information concerning any unexpected side effect, injury, toxicity, or sensitivity reaction or any unexpected incidence or severity thereof associated with clinical uses, studies, investigations, or tests, whether or not determined to be attributable to the new animal drug, except that this requirement shall not apply to the submission of information described in a written communication to the applicant from the Food and Drug Administration as types of information that may be submitted at other designated intervals. Unexpected as used in this paragraph refers to conditions or developments not previously submitted as part of the new animal drug application or not encountered during clinical trials of the drug, or conditions or developments occurring at a rate higher than shown by information previously submitted as part of the new animal drug application or at a rate higher than encountered during such clinical trials. (2) Information concerning any unusual failure of the new animal drug to exhibit its expected pharmacological activity. [40 FR 13807, Mar. 27, 1975, as amended at 54 FR 18280, Apr. 28, 1989] Each applicant shall maintain in a single accessible location: (a) A copy of the approved medicated feed mill license (Form FDA 3448) on the premises of the manufacturing establishment; and (b) Approved labeling for each Type B and/or Type C feed being manufactured on the premises of the manufacturing establishment or the facility where the feed labels are generated. [64 FR 63203, Nov. 19, 1999] (a) The Food and Drug Administration has received reports of side effects associated with the oral, injectable, and ophthalmic use of corticosteroid animal drugs. The use of these drugs administered orally or by injection has resulted in premature parturition when administered during the last trimester of pregnancy. Premature parturition may be followed by dystocia, fetal death, retained placenta, and metritis. Additionally, corticosteroids used in dogs, rabbits, and rodents during pregnancy have produced cleft palate in offspring. Use in dogs has resulted in other congenital anomalies, including deformed forelegs, phocomelia, and anasarca. Drugs subject to this section are required to carry the veterinary prescription legend and are subject to the labeling requirements of §201.105 of this chapter. (b) In view of these potentially serious side effects, the Food and Drug Administration has concluded that the labeling on or within packaged corticosteroid-containing preparations intended for animal use shall bear conspicuously the following warning statement:
Warning: Clinical and experimental data have demonstrated that corticosteroids administered orally or by injection to animals may induce the first stage of parturition if used during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis. Additionally, corticosteroids administered to dogs, rabbits, and rodents during pregnancy have resulted in cleft palate in offspring. Corticosteroids administered to dogs during pregnancy have also resulted in other congenital anomalies, including deformed forelegs, phocomelia, and anasarca. [49 FR 48535, Dec. 13, 1984] There has been an increasing interest in the use of injectable iron compounds for the prevention or treatment of iron-deficiency anemia in animals. Although some such preparations have been shown to be safe, such articles are regarded as new animal drugs within the meaning of the Federal Food, Drug, and Cosmetic Act. Accordingly, an approved new animal drug application is required prior to the marketing of such preparations within the jurisdiction of the act. In addition to the need for demonstrating the safety of such articles, the labeling of such preparations should not only recommend appropriate dosages of iron but also declare the amount (in milligrams) of available iron (Fe) per milliliter of the subject product. (a) What is free-choice medicated feed? For the purpose of this part, free-choice medicated feed is medicated feed that is placed in feeding or grazing areas and is not intended to be consumed fully at a single feeding or to constitute the entire diet of the animal. Free-choice feeds include, but are not limited to, medicated blocks (agglomerated feed compressed or rendered into a solid mass and cohesive enough to hold its form), mineral mixes, and liquid feed tank supplements (“lick tank” supplements) containing one or more new animal drugs. The manufacture of medicated free-choice feeds is subject to the current good manufacturing practice regulations in part 225 of this chapter for medicated feeds. (b) What types of approvals are required for new animal drugs intended for use in free-choice feed? New animal drugs intended for use in free-choice feed must be approved for such use under section 512 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360(b)), as: (1) An original new animal drug application (NADA), (2) A supplemental NADA, or (3) An abbreviated NADA. (c) What are the approval requirements for new animal drugs intended for use in free-choice feed? (1) An approval under section 512 of the act is required for any new animal drug intended for use in a free-choice feed. (2) An approved NADA for a Type A medicated article intended for use in free-choice feed must contain the following information: (i) Data, or reference to data in a master file (MF), showing that the target animal consumes the new animal drug in the Type C free-choice feed in an amount that is safe and effective (consumption/effectiveness data); and (ii) Data, or reference to data in a MF, showing the relevant ranges of conditions under which the drug will be chemically and physically stable in the Type C free-choice feed under field conditions. (d) How are consumption/effectiveness and/or stability data to be submitted? The data must be submitted as follows: (1) Directly in the NADA, by a sponsor; and/or (2) To an MF that a sponsor may then reference in its NADA with written consent of the MF holder. (e) What will be stated in the published approval for a new animal drug intended for use in free-choice feed? The approval of a new animal drug intended for use in free-choice feed, as published in this subchapter, will include: (1) The formula and/or specifications of the free-choice medicated feed, where the owner of this information requests such publication, or (2) A statement that the approval has been granted for a proprietary formula and/or specifications. (f) When is a medicated feed mill license required for the manufacture of a free-choice medicated feed? An approved medicated feed mill license is required for the manufacture of the following types of feeds: (1) All free-choice medicated feeds that contain a Category II drug, and (2) Free-choice medicated feeds that contain a Category I drug and use a proprietary formula and/or specifications. [69 FR 30197, May 27, 2004] (a) Section 512(i) of the act requires publication of names and addresses of sponsors of approved applications for new animal drugs. (b) In this section each name and address is identified by a numerical drug labeler code. The labeler codes identify the sponsors of the new animal drug applications associated with the regulations published pursuant to section 512(i) of the act. The codes appear in the appropriate regulations and serve as a reference to the names and addresses listed in this section. The drug labeler code is established pursuant to section 510 of the act. (c) The names, addresses, and drug labeler codes of sponsors of approved new animal drug applications are as follows: [40 FR 13807, Mar. 27, 1975] Editorial Note: For
Title 21: Food and Drugs
PART 510—NEW ANIMAL DRUGS
Section Contents
§ 510.3 Definitions and interpretations.
§ 510.4 Biologics; products subject to license control.
§ 510.7 Consignees of new animal drugs for use in the manufacture of animal feed.
§ 510.95 [Reserved]
§ 510.105 Labeling of drugs for use in milk-producing animals.
§ 510.106 Labeling of antibiotic and antibiotic-containing drugs intended for use in milk-producing animals.
§ 510.110 Antibiotics used in food-producing animals.
§ 510.112 Antibiotics used in veterinary medicine and for nonmedical purposes; required data.
§ 510.301 Records and reports concerning experience with animal feeds bearing or containing new animal drugs for which an approved medicated feed mill license application is in effect.
§ 510.305 Maintenance of copies of approved medicated feed mill licenses to manufacture animal feed bearing or containing new animal drugs.
§ 510.410 Corticosteroids for oral, injectable, and ophthalmic use in animals; warnings and labeling requirements.
§ 510.440 Injectable iron preparations.
§ 510.455 Requirements for free-choice medicated feeds.
§ 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications.
Subpart A—General Provisions
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§ 510.3 Definitions and interpretations.
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§ 510.4 Biologics; products subject to license control.
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§ 510.7 Consignees of new animal drugs for use in the manufacture of animal feed.
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§ 510.95 [Reserved]
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Subpart B—Specific Administrative Rulings and Decisions
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§ 510.105 Labeling of drugs for use in milk-producing animals.
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§ 510.106 Labeling of antibiotic and antibiotic-containing drugs intended for use in milk-producing animals.
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§ 510.110 Antibiotics used in food-producing animals.
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§ 510.112 Antibiotics used in veterinary medicine and for nonmedical purposes; required data.
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Subpart C [Reserved]
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Subpart D—Records and Reports
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§ 510.301 Records and reports concerning experience with animal feeds bearing or containing new animal drugs for which an approved medicated feed mill license application is in effect.
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§ 510.305 Maintenance of copies of approved medicated feed mill licenses to manufacture animal feed bearing or containing new animal drugs.
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Subpart E—Requirements for Specific New Animal Drugs
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§ 510.410 Corticosteroids for oral, injectable, and ophthalmic use in animals; warnings and labeling requirements.
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§ 510.440 Injectable iron preparations.
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§ 510.455 Requirements for free-choice medicated feeds.
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Subpart F [Reserved]
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Subpart G—Sponsors of Approved Applications
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§ 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications.
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(1) Alphabetical Listing of Sponsors------------------------------------------------------------------------ Drug Firm name and address labeler code------------------------------------------------------------------------Abbott Laboratories, North Chicago, IL 60064................ 000074ADM Alliance Nutrition, Inc., 1000 North 30th St., Quincy, 021930 IL 62305-3115..............................................ADM Animal Health & Nutrition Division, 1000 North 30th 017519 St., Box 1C, Quincy, IL 62305-3115.........................A & G Pharmaceuticals, Inc., 1030 West Commodore Blvd., 057699 Jackson, NJ 08527..........................................Ag-Mark, Inc., P.O. Box 127, Teachey, NC 28464.............. 024174Agri Laboratories, Ltd., P.O. Box 3103, St. Joseph, MO 64503 057561Agri-Tech, Inc., 4722 Broadway, Kansas City, MO 64112....... 017762Alaco, Inc., 1500 North Wilmot Rd., suite 290-C, Tucson, AZ 064146 85712......................................................Alpharma Inc., One Executive Drive, Fort Lee, NJ 07024...... 046573Alstoe, Ltd., Animal Health, Pera Innovation Park, 062408 Nottingham Rd., Melton Mowbray, Leicestershire, England LE13 0PB...................................................Altana Inc., 60 Baylis Rd., Melville, NY 11747.............. 025463American Pharmaceuticals Partners, Inc., 2045 North Cornell 063323 Ave., Melrose Park, IL 60160...............................Anika Therapeutics Inc., 236 West Cummings Park, Woburn, MA 060865 01801......................................................Animal Health Pharmaceuticals, LLC, 1805 Oak Ridge Circle, 068718 suite 101, St. Joseph, MO 64506............................Argent Laboratories, 8702 152d Ave. NE., Redmond, WA 98052.. 051212Ausa International, Inc., Rt. 8, P.O. Box 324-12, Tyler, TX 059521 75703......................................................Baxter Healthcare Corp., 95 Spring St., New Providence, NJ 010019 07974......................................................Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, 000859 Shawnee Mission, KS 66201..................................Bertek Pharmaceuticals, Inc., 12720 Dairy Ashford, Sugar 062794 Land, TX 77478.............................................Bioniche Animal Health USA, Inc., 119 Rowe Rd., Athens, GA 064847 30601......................................................Bioproducts, Inc., 320 Springside Dr., Suite 300, Fairlawn, 051359 OH 44333-2435..............................................Biopure Corp., 11 Hurley St., Cambridge, MA 02141........... 063075BioScience Division of Milk Specialties Co., 1902 Tennyson 032761 Lane, Madison, WI 53704....................................Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt 000010 Highway, St. Joseph, MO 64506-2002.........................Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, 061651 County Galway, Ireland.....................................Church & Dwight Co., Inc., 469 North Harrison St., 010237 Princeton, NJ 08543-5297...................................ConAgra Pet Products Co., 3902 Leavenworth St., Omaha, NE 021091 68105......................................................Contemporary Products, Inc., 3788 Elm Springs Rd., 055462 Springdale, AR 72764-6067..................................Cooperative Research Farms, Box 69, Charlotteville, NY 12036 051267Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 061623 24, Ireland................................................Custom Feed Blenders Corp., 540 Hawkeye Ave., Fort Dodge, IA 046987 50501......................................................Custom Feed Services Corp., 2100 N. 13th St., Norfolk, NE 017473 68701......................................................ECO LLC, 8209 Hollister Ave., Las Vegas, NV 89131........... 066916Elanco Animal Health, A Division of Eli Lilly & Co., 000986 Lilly Corporate Center, Indianapolis, IN 46285.............Endo Pharmaceuticals, Inc., 100 Painters Dr., Chadds Ford, 060951 PA 19317...................................................Eon Labs Manufacturing, Inc. 227-15 North Conduit Ave., 000185 Laurelton, NY 11413........................................Evsco Pharmaceuticals, An Affiliate of IGI, Inc., Box 209, 017030 Harding Hwy., Buena, NJ 08310..............................Farmland Industries, Inc., Kansas City, MO 64116............ 021676Farnam Companies, Inc., 301 West Osborn, Phoenix, AZ 85013- 017135 3928.......................................................Feed Service Co., Inc., 303 Lundin Blvd., P.O. Box 698, 030841 Mankato, MN 56001..........................................John J. Ferrante, 11 Fairway Lane, Trumbull, CT 06611....... 058034First Priority, Inc., 1585 Todd Farm Dr., Elgin, IL 60123... 058829Fleming Laboratories, Inc., P.O. Box 34384, Charlotte, NC 015565 28234......................................................Fort Dodge Animal Health, A Division of Wyeth Holdings 053501 Corp., P.O. Box 1339, Fort Dodge, IA 50501.................Fort Dodge Animal Health, Division of Wyeth, 800 Fifth St. 000856 NW., Fort Dodge, IA 50501..................................Furst-McNess Co., Freeport, IL 61032........................ 010439Gossett Nutrition, Inc., 1676 Cascade Dr., Marion, OH 43302. 050972G. C. Hanford Manufacturing Co., P.O. Box 1017, Syracuse, NY 010515 13201......................................................Halocarbon Laboratories, Division of Halocarbon Products 012164 Corp., 887 Kinderkamack Rd., P.O. Box 661, River Ridge, NJ 07661......................................................Happy Jack, Inc., Snow Hill, NC 28580....................... 023851Heska Corp., 1825 Sharp Point Dr., Fort Collins, CO 80525... 063604Hess & Clark, Inc., 944 Nandino Blvd., Lexington, KY 050749 40511......................................................Huvepharma AD, 33 James Boucher Blvd., Sophia 1407, Bulgaria 016592IDEXX Pharmaceuticals, Inc., 4249-105 Piedmont Pkwy., 065274 Greensboro, NC 27410.......................................I.M.S. Inc., 13619 Industrial Rd., Omaha, NE 68137.......... 050639International Nutrition, Inc., 7706 `I' Plaza, Omaha, NE 043733 68127......................................................Intervet Inc., P.O. Box 318, 29160 Intervet Lane, Millsboro, 057926 DE 19966...................................................IVX Animal Health, Inc., 3915 South 48th Street Ter., St. 059130 Joseph, MO 64503...........................................Ivy Laboratories, Div. of Ivy Animal Health, Inc., 8857 Bond 021641 Street, Overland Park, KS 66214............................J. C. Feed Mills, 1050 Sheffield, P.O. Box 224, Waterloo, IA 039741 50704......................................................Jazz Pharmaceuticals, Inc., 3180 Porter Dr., Palo Alto, CA 068727 94304......................................................K. C. Pharmacal, Inc., 8345 Melrose Dr., Lenexa, KS 66214... 038782Lloyd, Inc., 604 W. Thomas Ave., Shenandoah, IA 51601....... 061690Luitpold Pharmaceuticals, Inc., Animal Health Division, 010797 Shirley, NY 11967..........................................Macleod Pharmaceuticals, Inc., 2600 Canton Ct., Fort 058711 Collins, CO 80525..........................................Marsam Pharmaceuticals, LLC, Bldg. 31, 24 Olney Ave., Cherry 000209 Hill, NJ 08034.............................................Medicis Dermatologics, Inc., 8125 North Hayden Rd., 099207 Scottsdale, AZ 85258.......................................Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767- 054925 1861.......................................................Merial Ltd., 3239 Satellite Blvd., Bldg. 500, Duluth, GA 050604 30096-4640.................................................Micro Beef Technologies LTD, P.O. Box 9262, Amarillo, TX 047126 79105......................................................Mid-Continent Agrimarketing, Inc., 8833 Quivira Rd., 059620 Overland Park, KS 66214....................................Minrad, Inc., 836 Main St., 2d floor, Buffalo, NY 14202..... 060307Monsanto Co., 800 North Lindbergh Blvd., St. Louis, MO 63167 000911Natchez Animal Supply Co., 201 John R. Junkin Dr., Natchez, 049968 MS 39120...................................................Nicholas Piramal India Ltd. UK, 1st Floor, Alpine House, 066112 Unit II, Honeypot Lane, London, NW99RX, England, UK........Norbrook Laboratories, Ltd., Station Works, Newry BT35 6JP, 055529 Northern Ireland...........................................Norco Mills of Norfolk, Inc., P.O. Box 56, Norfolk, NE 68701 027190North American Nutrition Companies, Inc., C.S. 5002, 6531 017790 St., Rt. 503, Lewisburg, OH 45338..........................Novartis Animal Health US, Inc., 3200 Northline Ave., suite 058198 300, Greensboro, NC 27408..................................NutriBasics Co., North Highway 71, P.O. Box 1014, WIllmar, 053740 MN 56201...................................................Orion Corp., Orionintie 1, 02200 Espoo, Finland............. 052483OXIS International, Inc., 6040 N. Cutter Circle, Suite 317, 024991 Portland, OR 97217-3935....................................Parnell Laboratories (Aust) Pty. Ltd., Century Estate, unit 068504 6, 476 Gardeners Rd., Alexandria, New South Wales 2015, Australia..................................................Peavey Co., 730 Second Ave. South, Minneapolis, MN 55402.... 028459Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL 055246 32514......................................................Pennfield Oil Co., 14040 Industrial Rd., Omaha, NE 68144.... 048164Peptech Animal Health Pty, Ltd., 19-25 Khartoum Rd., 064288 Macquarie Park, New South Wales 2113, Australia............Pfizer, Inc., 235 East 42d St., New York, NY 10017.......... 000069Pharmaceutical Ventures, Ltd., P.O. Box D1400, Pomona, NY 050057 10970......................................................Pharmacia & Upjohn Co., a Division of Pfizer, Inc., 235 000009 East 42d St., New York, NY 10017...........................Pharmaq AS, Skogmo Industriomrade, N-7863 Overhalla, Norway. 015331Phibro Animal Health, 65 Challenger Rd., 3d floor, 066104 Ridgefield Park, NJ 07660..................................Planalquimica Industrial Ltda., Rua das Magnolias nr. 2405, 060728 Jardim das Bandeiras, CEP 13053-120, Campinas, Sao Paulo, Brazil.....................................................PR Pharmaceuticals, Inc., 1716 Heath Pkwy., Fort Collins, CO 067210 80524......................................................Purina Mills, Inc., P.O. Box 66812, St. Louis, MO 63166-6812 017800Quali-Tech Products, Inc., 318 Lake Hazeltine Drive, Chaska, 016968 MN 55318...................................................Ridley Block Operations Inc., 424 North Riverfront Dr., P.O. 068287 Box 8500, Mankato, MN 56002-8500...........................Ridley U.S. Holdings, Inc., 424 North Riverfront Dr., P.O. 067949 Box 8500, Mankato, MN 56002-8500...........................RMS Laboratories, Inc., 1903 East First St., Vidalia, GA 067292 30474......................................................Roche Vitamins, Inc., 45 Waterview Blvd., Parsippany, NJ 063238 07054-1298.................................................RSR Laboratories, Inc., 501 Fifth St., Bristol, TN 37620.... 058670R. P. Scherer North America, P.O. Box 5600, Clearwater, FL 011014 33518......................................................Schering-Plough Animal Health Corp., 556 Morris Ave., 000061 Summit, NJ 07901...........................................G. D. Searle LLC, Pharmacia Corp., 4901 Searle Pkwy., 000014 Skokie, IL 60077...........................................Seeco Inc., Box 1014, North Highway 71, Willmar, MN 56201... 011749Sioux Biochemical, Inc., 204 Third St. NW., Sioux Center, IA 063112 51250......................................................Southern Micro-Blenders, Inc., 3801 North Hawthorne St., 049685 Chattanooga, TN 37406......................................Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., 058005 Lenexa, KS 66215...........................................Springfield Milling Corp., Vigorena Feeds, Springfield, MN 035955 56087......................................................Squire Laboratories, Inc., 100 Mill St., Revere, MA 02151... 017153Summit Hill Laboratories, P.O. Box 535, Navesink, NJ 07752.. 037990Technology Transfer, Inc., 33 East Broadway, suite 190, 067647 Columbia, MO 65203.........................................Texas Vitamin Co., P.O. Box 18417, 10695 Aledo St., Dallas, 000842 TX 57218...................................................Triple ``F'', Inc., 10104 Douglas Ave., Des Moines, IA 50322 011490United Vaccines, A Harlan Sprague Dawley, Inc., Co., P.O. 058639 Box 4220, Madison, WI 53711................................Vetem, S.p.A., Viale E. Bezzi 24, 20146 Milano, Italy....... 055882Veterinary Research Associates, Inc., 2817 West Country Rd. 064408 54G, Fort Collins, CO 80524................................Veterinary Service, Inc., 416 North Jefferson St., P.O. Box 033008 2467, Modesto, CA 95354....................................Vétoquinol N.-A., Inc., 2000 chemin Georges, 059320 Lavaltrie (PQ), Canada, J5T 3S5............................Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137.... 051311Walco International, Inc., 15 West Putnam, Porterville, CA 049185 93257Waterloo Mills Co., 2050 Mitchell Ave., Waterloo, IA 50704.. 017139Watson Laboratories, Inc., 620 North 51st Ave., Phoenix, AZ 000402 85043-4705.................................................Wayne Feed Division, Continental Grain Co., P.O. Box 459, 034936 Libertyville, IL 60048.....................................Webel Feeds, Inc., R.R. 3, Pittsfield, IL 62363............. 035098Wellmark International, 1501 East Woodfield Rd., suite 200 011536 West, Schaumburg, IL 60173.................................Wendt Laboratories , Inc., 100 Nancy Dr., Belle Plaine, MN 015579 56011......................................................West Agro, Inc., 11100 N. Congress Ave., Kansas City, MO 033392 64153......................................................Western Chemical, Inc., 1269 Lattimore Rd., Ferndale, WA 050378 98248......................................................West-Ward Pharmaceutical Corp., 465 Industrial Way West, 000143 Eatontown, NJ 07724........................................Wildlife Laboratories, Inc., 1401 Duff Dr., Suite 600, Fort 053923 Collins, CO 80524..........................................Wyeth Laboratories, Division American Home Products Corp., 000008 P.O. Box 8299, Philadelphia, PA 19101......................Yoder Feed, Division of Yoder, Inc., Kalona, IA 52247....... 035369------------------------------------------------------------------------
(2) Numerical Listing of Sponsors------------------------------------------------------------------------ Drug labeler code Firm name and address------------------------------------------------------------------------000008............................. Wyeth Laboratories, Division American Home Products Corp., P.O. Box 8299, Philadelphia, PA 19101.000009............................. Pharmacia & Upjohn Co., a Division of Pfizer, Inc., 235 East 42d St., New York, NY 10017.000010............................. Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt Highway, St. Joseph, MO 64506-2002.000014............................. G. D. Searle LLC, Pharmacia Corp., 4901 Searle Pkwy., Skokie, IL 60077.000061............................. Schering-Plough Animal Health Corp., 556 Morris Ave., Summit, NJ 07901.000069............................. Pfizer, Inc., 235 East 42d St., New York, NY 10017.000074............................. Abbott Laboratories, North Chicago, IL 60064.000143............................. West-Ward Pharmaceutical Corp., 465 Industrial Way West, Eatontown, NJ 07724000185............................. Eon Labs Manufacturing, Inc., 227- 15 North Conduit Ave., Laurelton, NY 11413.000209............................. Marsam Pharmaceuticals, LLC, Bldg. 31, 24 Olney Ave., Cherry Hill, NJ 08034.000402............................. Watson Laboratories, Inc., 620 North 51st Ave., Phoenix, AZ 85043- 4705.000842............................. Texas Vitamin Co., P.O. Box 18417, 10695 Aledo St., Dallas, TX 57218.000856............................. Fort Dodge Animal Health, Division of Wyeth, 800 Fifth St. NW., Fort Dodge, IA 50501.000859............................. Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee Mission, KS 66201000911............................. Monsanto Co., 800 North Lindbergh Blvd., St. Louis, MO 63167.000986............................. Elanco Animal Health, A Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285.010019............................. Baxter Healthcare Corp., 95 Spring St., New Providence, NJ 07974.010237............................. Church & Dwight Co., Inc., 469 North Harrison St., Princeton, NJ 08543-5297.010439............................. Furst-McNess Co., Freeport, IL 61032.010515............................. G. C. Hanford Manufacturing Co., P.O. Box 1017, Syracuse, NY 13201.010797............................. Luitpold Pharmaceuticals, Inc., Animal Health Division, Shirley, NY 11967.011014............................. R. P. Scherer North America, P.O. Box 5600, Clearwater, FL 33518.011490............................. Triple ``F'', Inc., 10104 Douglas Ave., Des Moines, IA 50322.011536............................. Wellmark International, 1501 East Woodfield Rd., suite 200 West, Schaumburg, IL 60173011749............................. Seeco Inc., Box 1014, North Highway 71, Willmar, MN 56201.012164............................. Halocarbon Laboratories, Division of Halocarbon Products Corp., 887 Kinderkamack Rd., P.O. Box 661, River Ridge, NJ 07661.015331............................. Pharmaq AS, Skogmo Industriomrade, N-7863 Overhalla, Norway.015565............................. Fleming Laboratories, Inc., P.O. Box 34384, Charlotte, NC 28234.015579............................. Wendt Laboratories, Inc., 100 Nancy Dr., Belle Plaine, MN 56011.016592............................. Huvepharma AD, 33 James Boucher Blvd., Sophia 1407, Bulgaria016968............................. Quali-Tech Products, Inc., 318 Lake Hazeltine Dr., Chaska, MN 55318.017030............................. Evsco Pharmaceuticals, An Affiliate of IGI, Inc., Box 209, Harding Hwy., Buena, NJ 08310.017135............................. Farnam Companies, Inc., 301 West Osborn, Phoenix, AZ 85013-3928.017139............................. Waterloo Mills Co., 2050 Mitchell Ave., Waterloo, IA 50704.017153............................. Squire Laboratories, Inc., 100 Mill St., Revere, MA 02151.017473............................. Custom Feed Services Corp., 2100 N. 13th St., Norfolk, NE 68701.017519............................. ADM Animal Health & Nutrition Division, 1000 North 30th St., Box 1C, Quincy, IL 62305-3115017762............................. Agri-Tech, Inc., 4722 Broadway, Kansas City, MO 64112.017790............................. North American Nutrition Companies, Inc., C.S. 5002, 6531 St., Rt. 503, Lewisburg, OH 45338.017800............................. Purina Mills, Inc., P.O. Box 66812, St. Louis, MO 63166-6812.021091............................. ConAgra Pet Products Co., 3902 Leavenworth St., Omaha, NE 68105.021641............................. Ivy Laboratories, Div. of Ivy Animal Health, Inc., 8857 Bond Street, Overland Park, KS 66214.021676............................. Farmland Industries, Inc., Kansas City, MO 64116.021930............................. ADM Alliance Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305- 3115023851............................. Happy Jack, Inc., Snow Hill, NC 28580.024174............................. Ag-Mark, Inc., P.O. Box 127, Teachey, NC 28464.024991............................. OXIS International, Inc., 6040 N. Cutter Circle, Suite 317 Portland, OR 97217-3935.025463............................. Altana Inc., 60 Baylis Rd., Melville, NY 11747.027190............................. Norco Mills of Norfolk, Inc., P.O. Box 56, Norfolk, NE 68701.028459............................. Peavey Co., 730 Second Ave. South, Minneapolis, MN 55402.030841............................. Feed Service Co., Inc., 303 Lundin Blvd., P.O. Box 698, Mankato, MN 56001.032761............................. BioScience Division of Milk Specialties Co., 1902 Tennyson Lane, Madison, WI 53704033008............................. Veterinary Service, Inc., 416 North Jefferson St., P.O. Box 2467, Modesto, CA 95354.033392............................. West Agro, Inc., 11100 N. Congress Ave., Kansas City, MO 64153.034936............................. Wayne Feed Division, Continental Grain Co., P.O. Box 459, Libertyville, IL 60048.035098............................. Webel Feeds, Inc., R.R. 3, Pittsfield, IL 62363.035369............................. Yoder Feed, Division of Yoder, Inc., Kalona, IA 52247.035955............................. Springfield Milling Corp., Vigorena Feeds, Springfield, MN 56087.037990............................. Summit Hill Laboratories, P.O. Box 535, Navesink, NJ 07752.038782............................. K. C. Pharmacal, Inc., 8345 Melrose Dr., Lenexa, KS 66214.039741............................. J. C. Feed Mills, 1050 Sheffield, P.O. Box 224, Waterloo, IA 50704.043733............................. International Nutrition, Inc., 7706 `I' Plaza, Omaha, NE 68127046573............................. Alpharma Inc., One Executive Drive, Fort Lee, NJ 07024.046987............................. Custom Feed Blenders Corp., 540 Hawkeye Ave., Fort Dodge, IA 50501.047126............................. Micro Beef Technologies LTD, P.O. Box 9262, Amarillo, TX 79105.048164............................. Pennfield Oil Co., 14040 Industrial Rd., Omaha, NE 68144.049185............................. Walco International, Inc., 15 West Putnam, Porterville, CA 93257.049685............................. Southern Micro-Blenders, Inc., 3801 North Hawthorne St., Chattanooga, TN 37406.049968............................. Natchez Animal Supply Co., 201 John R. Junkin Dr., Natchez, MS 39120.050057............................. Pharmaceutical Ventures, Ltd., P.O. Box D1400, Pomona, NY 10970.050378............................. Western Chemical, Inc., 1269 Lattimore Rd., Ferndale, WA 98248.050604............................. Merial Ltd., 3239 Satellite Blvd., Bldg. 500, Duluth, GA 30096-4640.050639............................. I.M.S. Inc., 13619 Industrial Rd., Omaha, NE 68137.050749............................. Hess & Clark, Inc., 944 Nandino Blvd., Lexington, KY 40511.050972............................. Gossett Nutrition, Inc., 1676 Cascade Dr., Marion, OH 43302.051212............................. Argent Laboratories, 8702 152d Ave. NE., Redmond, WA 98052.051267............................. Cooperative Research Farms, Box 69, Charlotteville, NY 12036.051311............................. Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137.051359............................. Bioproducts, Inc., 320 Springside Dr., Suite 300, Fairlawn, OH 44141.052483............................. Orion Corp., Orionintie 1, 02200 Espoo, Finland.053501............................. Fort Dodge Animal Health, A Division of Wyeth Holdings Corp., P.O. Box 1339, Fort Dodge, IA 50501.053740............................. NutriBasics Co., North Highway 71, P.O. Box 1014, WIllmar, MN 56201.053923............................. Wildlife Laboratories, Inc., 1401 Duff Dr., Suite 600, Fort Collins, CO 80524.054925............................. Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767-1861.055246............................. Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL 32514.055462............................. Contemporary Products, Inc., 3788 Elm Springs Rd., Springdale, AR 72764-6067.055529............................. Norbrook Laboratories, Ltd., Station Works, Newry BT35 6JP, Northern Ireland.055882............................. Vetem, S.p.A., Viale E. Bezzi 24, 20146 Milano, Italy.057561............................. Agri Laboratories, Ltd., P.O. Box 3103, St. Joseph, MO 64503.057699............................. A & G Pharmaceuticals, Inc., 1030 West Commodore Blvd., Jackson, NJ 08527.057926............................. Intervet, Inc., P.O. Box 318, 29160 Intervet Lane, Millsboro, DE 19966.058005............................. Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215.058034............................. John J. Ferrante, 11 Fairway Lane, Trumbull, CT 06611.058198............................. Novartis Animal Health US, Inc., 3200 Northline Ave., suite 300, Greensboro, NC 27408.058639............................. United Vaccines, A Harlan Sprague Dawley, Inc., Co., P.O. Box 4220, Madison, WI 53711.058670............................. RSR Laboratories, Inc., 501 Fifth St., Bristol, TN 37620.058711............................. Macleod Pharmaceuticals, Inc., 2600 Canton Ct., Fort Collins, CO 80525.058829............................. First Priority, Inc., 1585 Todd Farm Dr., Elgin, IL 60123.059130............................. IVX Animal Health, Inc., 3915 South 48th Street Ter., St. Joseph, MO 64503059320............................. Vétoquinol N.-A., Inc., 2000 chemin Georges, Lavaltrie (PQ), Canada, J5T 3S5.059521............................. Ausa International, Inc., Rt. 8, P.O. Box 324-12, Tyler, TX 75703.059620............................. Mid-Continent Agrimarketing, Inc., 8833 Quivira Rd., Overland Park, KS 66214.Blvd., St. Louis, MO 63167.060307............................. Minrad, Inc., 836 Main St., 2d floor, Buffalo, NY 14202.060728............................. Planalquimica Industrial Ltda., Rua das Magnolias nr. Jardim das Bandeiras, CEP 13053-120, Campinas, Sao Alto, Brazil.060865............................. Anika Therapeutics Inc., 236 West Cummings Park, Woburn, MA 01801.060951............................. Endo Pharmaceuticals, Inc., 100 Painters Dr., Chadds Ford, PA 19317.061623............................. Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland.061651............................. Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, County Galway, Ireland.061690............................. Lloyd, Inc., 604 W. Thomas Ave., Shenandoah, IA 51601.062408............................. Alstoe, Ltd., Animal Health, Pera Innovation Park, Nottingham Rd., Melton Mowbray, Leicestershire, England LE13 0PB.062794............................. Bertek Pharmaceuticals, Inc., 12720 Dairy Ashford, Sugar Land, TX 77478063075............................. Biopure Corp., 11 Hurley St., Cambridge, MA 02141.063112............................. Sioux Biochemical, Inc., 204 Third St. NW., Sioux Center, IA 51250.063238............................. Roche Vitamins, Inc., 45 Waterview Blvd., Parsippany, NJ 07054-1298.063323............................. American Pharmaceuticals Partners, Inc., 2045 North Cornell Ave., Melrose Park, IL 60160.063604............................. Heska Corp., 1825 Sharp Point Dr., Fort Collins, CO 80525.064146............................. Alaco, Inc., 1500 North Wilmot Rd., suite 290-C, Tucson, AZ 85712.064288............................. Peptech Animal Health Pty, Ltd., 19- 25 Khartoum Rd., Macquarie Park, New South Wales 2113, Australia064408............................. Veterinary Research Associates, Inc., 2817 West Country Rd. 54G, Fort Collins, CO 80524064847............................. Bioniche Animal Health USA, Inc., 119 Rowe Rd., Athens, GA 30601065274............................. IDEXX Pharmaceuticals, Inc., 4249- 105 Piedmont Pkwy., Greensboro, NC 27410066104............................. Phibro Animal Health, 65 Challenger Rd., 3d floor, Ridgefield Park, NJ 07660066112............................. Nicholas Piramal India Ltd. UK, 1st Floor, Alpine House, Unit II, Honeypot Lane, London, NW99RX, England, UK066916............................. ECO LLC, 8209 Hollister Ave., Las Vegas, NV 89131067210............................. PR Pharmaceuticals, Inc., 1716 Heath Pkwy., Fort Collins, CO 80524067292............................. RMS Laboratories, Inc., 1903 East First St., Vidalia, GA 30474067647............................. Technology Transfer, Inc., 33 East Broadway, suite 190, Columbia, MO 65203067949............................. Ridley U.S. Holdings, Inc., 424 N. Riverfront Dr., P.O. Box 8500, Mankato, MN 56002-8500068287............................. Ridley Block Operations Inc., 424 North Riverfront Dr., P.O. Box 8500, Mankato, MN 56002-8500068504............................. Parnell Laboratories (Aust) Pty. Ltd., Century Estate, unit 6, 476 Gardeners Rd., Alexandria, New South Wales 2015, Australia068718............................. Animal Health Pharmaceuticals, LLC, 1805 Oak Ridge Circle, suite 101, St. Joseph, MO 64506068727............................. Jazz Pharmaceuticals, Inc., 3180 Porter Dr., Palo Alto, CA 94304099207............................. Medicis Dermatologics, Inc., 8125 North Hayden Rd., Scottsdale, AZ 85258------------------------------------------------------------------------
