21 CFR 510.600 - Names, addresses, and drug labeler codes of sponsors of approved applications.

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§ 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications.

(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:

(1) Alphabetical Listing of Sponsors

Firm name and address Drug labeler code
A & G Pharmaceuticals, Inc., 1030 West Commodore Blvd., Jackson, NJ 08527 057699
Accord Healthcare, Inc., 1009 Slater Rd., suite 210-B, Durham, NC 27703 016729
ADM Alliance Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305-3115 012286
Agri Laboratories, Ltd., P.O. Box 3103, St. Joseph, MO 64503 057561
Agri-Tech, Inc., 4722 Broadway, Kansas City, MO 64112 017762
Akorn Animal Health, Inc., 1925 West Field Ct., suite 300, Lake Forest, IL 60045 059399
Alaco, Inc., 1500 North Wilmot Rd., suite 290-C, Tucson, AZ 85712 064146
American Pharmaceuticals and Cosmetics, Inc., 1401 Joel East Rd., Fort Worth, TX 76140 065531
Anika Therapeutics Inc., 236 West Cummings Park, Woburn, MA 01801 060865
AquaBounty Technologies, Inc., Two Clock Tower Pl., suite 395, Maynard, MA 01754 086053
Ark Sciences, Inc., 1101 East 33rd St., suite B304, Baltimore, MD 21218 076175
Aratana Therapeutics, Inc., 11400 Tomahawk Creek Pkwy., Leawood, KS 66211 086026
Aurora Pharmaceutical, LLC, 1196 Highway 3 South, Northfield, MN 55057-3009 051072
Axcentive SARL, Chemin de Champouse, Quartier Violesi, 13320 Bouc Bel Air, France 086009
B.L. Mitchell, Inc., 103 Hwy. 82 E., Leland, MS 38756 067188
Baxter Healthcare Corp., One Baxter Pkwy., Deerfield, IL 60015. 010019
Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee Mission, KS 66201 000859
Belcher Pharmaceuticals, LLC, 6911 Bryan Dairy Rd., Largo, FL 33777 062250
Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt Highway, St. Joseph, MO 64506-2002 000010
Cephazone Pharma, LLC, 250 East Bonita Ave., Pomona, CA 91767 068330
Ceva Sante Animale, 10 Avenue de la Ballastière, 33500 Libourne, France 013744
Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, County Galway, Ireland 061651
ConAgra Pet Products Co., 3902 Leavenworth St., Omaha, NE 68105 021091
Cooperative Research Farms, Box 69, Charlotteville, NY 12036 051267
Cronus Pharma LLC, 2 Tower Center Blvd., Suite 1101, East Brunswick, NJ 08816 069043
Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland 061623
Dechra, Ltd., Snaygill Industrial Estate, Keighley Rd., Skipton, North Yorkshire, BD23 2RW, United Kingdom 043264
ECO LLC, 344 Nassau St., Princeton, NJ 08540 066916
Elanco Animal Health, A Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285 000986
Elanco US, Inc., 2500 Innovation Way, Greenfield, IN 46140 058198
Farnam Companies, Inc., 301 West Osborn, Phoenix, AZ 85013-3928 017135
First Priority, Inc., 1590 Todd Farm Dr., Elgin, IL 60123 058829
Fleming Laboratories, Inc., P.O. Box 34384, Charlotte, NC 28234 015565
Fougera Pharmaceuticals, Inc., P.O. Box 2006, 60 Baylis Rd., Melville, NY 11747 025463
G. C. Hanford Manufacturing Co., P.O. Box 1017, Syracuse, NY 13201 010515
GTC Biotherapeutics, Inc., 175 Crossing Blvd., Framingham, MA 01702 042976
Halocarbon Products Corp., 887 Kinderkamack Rd., River Edge, NJ 07661 012164
Happy Jack, Inc., Snow Hill, NC 28580 023851
Hemoglobin Oxygen Therapeutics, LLC, 674 Souder Rd., Souderton, PA 18964 063075
Heska Corp., 1825 Sharp Point Dr., Fort Collins, CO 80525 063604
Hikma International Pharmaceuticals LLC, P.O. Box 182400, Bayader Wadi Seer, Amman, Jordan 11118 059115
Hospira, Inc., 275 North Field Dr., Lake Forest, IL 60045 000409
HQ Specialty Pharma Corp., 120 Rte. 17 North, Suite 130, Paramus, NJ 07652 042791
Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sofia, Bulgaria 016592
IDEXX Pharmaceuticals, Inc., 7009 Albert Pick Rd., Greensboro, NC 27409 065274
IMPAX Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544 000115
Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940 000061
iVaoes Animal Health, 4300 SW 73rd Ave., suite 110, Miami, FL 33155 086064
JBS United Animal Health II LLC, 322 S. Main St., Sheridan, IN 46069 051233
Jurox Pty. Ltd., 85 Gardiner St., Rutherford, NSW 2320, Australia 049480
LFB USA, Inc., 175 Crossing Blvd., Framingham, MA 01702 086047
Lloyd, Inc., 604 W. Thomas Ave., Shenandoah, IA 51601 061690
Luitpold Pharmaceuticals, Inc., Animal Health Division, Shirley, NY 11967 010797
Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767-1861 054925
Medicis Dermatologics, Inc., 8125 North Hayden Rd., Scottsdale, AZ 85258 099207
Merial, Inc., 3239 Satellite Blvd., Bldg. 500, Duluth, GA 30096-4640 050604
Mylan Institutional, Inc., 12720 Dairy Ashford Rd., Sugar Land, TX 77478 051079
Mylan Institutional LLC, 4901 Hiawatha Dr., Rockford, IL 61103 063286
Natchez Animal Supply Co., 201 John R. Junkin Dr., Natchez, MS 39120 049968
Neogen Corp., 944 Nandino Blvd., Lexington, KY 40511 059051
Nexcyon Pharmaceuticals, Inc., 644 West Washington Ave., Madison, WI 53719 050929
Norbrook Laboratories, Ltd., Station Works, Newry BT35 6JP, Northern Ireland 055529
Oasmia Pharmaceutical AB, Vallongatan 1, 75228 Uppsala, Sweden 052818
Orion Corp., Orionintie 1, 02200 Espoo, Finland 052483
OXIS International, Inc., 6040 N. Cutter Circle, Suite 317, Portland, OR 97217-3935 024991
Parnell Technologies Pty. Ltd., unit 4, 476 Gardeners Rd., Alexandria, New South Wales 2015, Australia 068504
Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL 32514 055246
Pharmaceutical Ventures, Ltd., P.O. Box D1400, Pomona, NY 10970 050057
Pharmacosmos, Inc., 776 Mountain Blvd., Watchung, NJ 07069 042552
Pharmaq AS, Skogmo Industriomrade, N-7863 Overhalla, Norway. 015331
Pharmgate LLC, 1015 Ashes Dr., Suite 102, Wilmington, NC 28405 069254
Phibro Animal Health Corp., GlenPointe Centre East, 3d floor, 300 Frank W. Burr Blvd., suite 21, Teaneck, NJ 07666 066104
Piramal Critical Care, Inc., 3850 Schelden Circle, Bethlehem, PA 18017 066794
Piramal Healthcare Ltd., Piramal Tower, Ganpatrao Kadam Marg, Lower Parel, Mumbai - 400 013, India 065085
Planalquimica Industrial Ltda., Rua das Magnolias nr. 2405, Jardim das Bandeiras, CEP 13053-120, Campinas, Sao Paulo, Brazil 060728
Purina Animal Nutrition LLC, 1080 County Road F West, Shoreview, MN 55126-2910 017800
Putney, Inc., One Monument Sq., Suite 400, Portland, ME 04101 026637
Quo Vademus, LLC, 277 Faison McGowan Rd., Kenansville, NC 28349 076475
Ridley Block Operations Inc., 424 North Riverfront Dr., P.O. Box 8500, Mankato, MN 56002-8500 068287
Ridley U.S. Holdings, Inc., 424 North Riverfront Dr., P.O. Box 8500, Mankato, MN 56002-8500 067949
RSR Laboratories, Inc., 501 Fifth St., Bristol, TN 37620 058670
Sioux Biochemical, Inc., 204 Third St. NW., Sioux Center, IA 51250 063112
SmartVet USA, Inc., 22201 West Innovation Dr., Suite 170A, Olathe, KS 66061-1304 086001
Sogeval S.A., 200 Avenue de Mayenne, 53000 Laval, France 059120
Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215 058005
Squire Laboratories, Inc., 100 Mill St., Revere, MA 02151 017153
Strategic Veterinary Pharmaceuticals, Inc., 100 NW. Airport Rd., St. Joseph, MO 64503 054628
Summit Hill Laboratories, P.O. Box 535, Navesink, NJ 07752 037990
Superior Equine Pharmaceuticals, Inc., Pleasant Grove, UT 84062 027053
Taro Pharmaceuticals U.S.A., Inc., 3 Skyline Dr., Hawthorne, NY 10532 051672
Therio, Inc., 8801 Anderson Ave., Manhattan, KS 66503 052923
Thorn Bioscience LLC, 1044 East Chestnut St., Louisville, KY 40204 051330
Vétoquinol N.-A., Inc., 2000 chemin Georges, Lavaltrie (PQ), Canada, J5T 3S5 059320
Vétoquinol USA, Inc., 4250 N. Sylvania Ave., Fort Worth, TX 76137 017030
Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137 051311
Walco International, Inc., 15 West Putnam, Porterville, CA 93257 049185
Watson Laboratories, Inc., 311 Bonnie Circle, Corona, CA 92880. 000402
Western Chemical, Inc., 1269 Lattimore Rd., Ferndale, WA 98248 050378
Wildlife Laboratories, Inc., 1401 Duff Dr., Suite 600, Fort Collins, CO 80524 053923
Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 054771

(2) Numerical Listing of Sponsors

Drug labeler code Firm name and address
000010 Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt Highway, St. Joseph, MO 64506-2002.
000061 Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940.
000115 IMPAX Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544.
000402 Watson Laboratories, Inc., 311 Bonnie Circle, Corona, CA 92880.
000409 Hospira Inc., 275 North Field Dr., Lake Forest, IL 60045.
000859 Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee Mission, KS 66201.
000986 Elanco Animal Health, A Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285.
010019 Baxter Healthcare Corp., One Baxter Pkwy., Deerfield, IL 60015.
010515 G. C. Hanford Manufacturing Co., P.O. Box 1017, Syracuse, NY 13201.
010797 Luitpold Pharmaceuticals, Inc., Animal Health Division, Shirley, NY 11967.
012164 Halocarbon Products Corp., 887 Kinderkamack Rd., River Edge, NJ 07661.
012286 ADM Alliance Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305-3115.
012578 Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Belgium.
013744 Ceva Sante Animale, 10 Avenue de la Ballastière, 33500 Libourne, France.
015331 Pharmaq AS, Skogmo Industriomrade, N-7863 Overhalla, Norway.
015565 Fleming Laboratories, Inc., P.O. Box 34384, Charlotte, NC 28234.
016592 Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sofia, Bulgaria
016729 Accord Healthcare, Inc., 1009 Slater Rd., suite 210-B, Durham, NC 27703.
017030 Vétoquinol USA, Inc., 4250 N. Sylvania Ave., Fort Worth, TX 76137.
017135 Farnam Companies, Inc., 301 West Osborn, Phoenix, AZ 85013-3928.
017153 Squire Laboratories, Inc., 100 Mill St., Revere, MA 02151.
017762 Agri-Tech, Inc., 4722 Broadway, Kansas City, MO 64112.
017800 Purina Animal Nutrition, 1080 County Road F West, Shoreview, MN 55126-2910.
021091 ConAgra Pet Products Co., 3902 Leavenworth St., Omaha, NE 68105.
023851 Happy Jack, Inc., Snow Hill, NC 28580.
024991 OXIS International, Inc., 6040 N. Cutter Circle, Suite 317 Portland, OR 97217-3935.
025463 Fougera Pharmaceuticals, Inc., P.O. Box 2006, 60 Baylis Rd., Melville, NY 11747.
026637 Putney, Inc., One Monument Sq., Suite 400, Portland, ME 04101.
027053 Superior Equine Pharmaceuticals, Inc., Pleasant Grove, UT 84062.
037990 Summit Hill Laboratories, P.O. Box 535, Navesink, NJ 07752.
042552 Pharmacosmos, Inc., 776 Mountain Blvd., Watchung, NJ 07069.
042791 HQ Specialty Pharma Corp., 120 Rte. 17 North, Suite 130, Paramus, NJ 07652.
042976 GTC Biotherapeutics, Inc., 175 Crossing Blvd., Framingham, MA 01702.
043264 Dechra, Ltd., Snaygill Industrial Estate, Keighley Rd., Skipton, North Yorkshire, BD23 2RW, United Kingdom.
049185 Walco International, Inc., 15 West Putnam, Porterville, CA 93257.
049480 Jurox Pty. Ltd., 85 Gardiner St., Rutherford, NSW 2320, Australia.
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, Inc., 3239 Satellite Blvd., Bldg. 500, Duluth, GA 30096-4640.
050929 Nexcyon Pharmaceuticals, Inc., 644 West Washington Ave., Madison, WI 53719.
051072 Aurora Pharmaceutical, LLC, 1196 Highway 3 South, Northfield, MN 55057-3009.
051079 Mylan Institutional, Inc., 12720 Dairy Ashford Rd., Sugar Land, TX 77478.
051233 JBS United Animal Health II LLC, 322 S. Main St., Sheridan, IN 46069.
051267 Cooperative Research Farms, Box 69, Charlotteville, NY 12036.
051311 Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137.
051330 Thorn Bioscience LLC, 1044 East Chestnut St., Louisville, KY 40204.
051672 Taro Pharmaceuticals U.S.A., Inc., 3 Skyline Dr., Hawthorne, NY 10532.
052483 Orion Corp., Orionintie 1, 02200 Espoo, Finland.
052818 Oasmia Pharmaceutical AB, Vallongatan 1, 75228 Uppsala, Sweden.
052923 Therio, Inc., 8801 Anderson Ave., Manhattan, KS 66503.
053923 Wildlife Laboratories, Inc., 1401 Duff Dr., Suite 600, Fort Collins, CO 80524.
054628 Strategic Veterinary Pharmaceuticals, Inc., 100 NW. Airport Rd., St. Joseph, MO 64503.
054771 Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007.
054925 Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767-1861.
055246 Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL 32514.
055529 Norbrook Laboratories, Ltd., Station Works, Newry BT35 6JP, Northern Ireland.
057561 Agri Laboratories, Ltd., P.O. Box 3103, St. Joseph, MO 64503.
057699 A & G Pharmaceuticals, Inc., 1030 West Commodore Blvd., Jackson, NJ 08527.
058005 Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215.
058198 Elanco US, Inc., 2500 Innovation Way, Greenfield, IN 46140.
058670 RSR Laboratories, Inc., 501 Fifth St., Bristol, TN 37620.
058829 First Priority, Inc., 1590 Todd Farm Dr., Elgin, IL 60123.
059051 Neogen Corp., 944 Nandino Blvd., Lexington, KY 40511.
059115 Hikma International Pharmaceuticals LLC, P.O. Box 182400, Bayader Wadi Seer, Amman, Jordan 11118.
059120 Sogeval S.A., 200 Avenue de Mayenne, 53000 Laval, France.
059320 Vétoquinol N.-A., Inc., 2000 chemin Georges, Lavaltrie (PQ), Canada, J5T 3S5.
059399 Akorn Animal Health, Inc., 1925 West Field Ct., suite 300, Lake Forest, IL 60045
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.
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.
062250 Belcher Pharmaceuticals, LLC, 6911 Bryan Dairy Rd., Largo, FL 33777.
062794 Mylan Bertek Pharmaceuticals, Inc., 12720 Dairy Ashford, Sugar Land, TX 77478.
063075 Hemoglobin Oxygen Therapeutics, LLC, 674 Souder Rd., Souderton, PA 18964.
063112 Sioux Biochemical, Inc., 204 Third St. NW., Sioux Center, IA 51250.
063286 Mylan Institutional, LLC, 4901 Hiawatha Dr., Rockford, IL 61103.
063604 Heska Corp., 1825 Sharp Point Dr., Fort Collins, CO 80525.
064146 Alaco, Inc., 1500 North Wilmot Rd., suite 290-C, Tucson, AZ 85712.
065085 Piramal Healthcare Ltd., Piramal Tower, Ganpatrao Kadam Marg, Lower Parel, Mumbai - 400 013, India.
065274 IDEXX Pharmaceuticals, Inc., 7009 Albert Pick Rd., Greensboro, NC 27409.
065531 American Pharmaceuticals and Cosmetics, Inc., 1401 Joel East Rd., Fort Worth, TX 76140.
066104 Phibro Animal Health Corp., GlenPointe Centre East, 3d floor, 300 Frank W. Burr Blvd., suite 21, Teaneck, NJ 07666.
066794 Piramal Critical Care, Inc., 3850 Schelden Circle, Bethlehem, PA 18017.
066916 ECO LLC, 344 Nassau St., Princeton, NJ 08540.
067188 B.L. Mitchell, Inc., 103 Hwy. 82 E., Leland, MS 38756.
067949 Ridley U.S. Holdings, Inc., 424 N. Riverfront Dr., P.O. Box 8500, Mankato, MN 56002-8500.
068287 Ridley Block Operations Inc., 424 North Riverfront Dr., P.O. Box 8500, Mankato, MN 56002-8500.
068330 Cephazone Pharma, LLC, 250 East Bonita Ave., Pomona, CA 91767.
068504 Parnell Technologies Pty. Ltd., unit 4, 476 Gardeners Rd., Alexandria, New South Wales 2015, Australia.
069043 Cronus Pharma LLC, 2 Tower Center Blvd., Suite 1101, East Brunswick, NJ 08816.
069254 Pharmgate LLC, 1015 Ashes Dr., Suite 102, Wilmington, NC 28405.
076175 Ark Sciences, Inc., 1101 East 33rd St., suite B304, Baltimore, MD 21218.
076475 Quo Vademus, LLC, 277 Faison McGowan Rd., Kenansville, NC 28349.
086001 SmartVet USA, Inc., 22201 West Innovation Dr., Suite 170A, Olathe, KS 66061-1304.
086009 Axcentive SARL, Chemin de Champouse, Quartier Violesi, 13320 Bouc Bel Air, France.
086026 Aratana Therapeutics, Inc., 11400 Tomahawk Creek Pkwy., Leawood, KS 66211
086047 LFB USA, Inc., 175 Crossing Blvd., Framingham, MA 01702.
086053 AquaBounty Technologies, Inc., Two Clock Tower Pl., suite 395, Maynard, MA 01754.
086064 iVaoes Animal Health, 4300 SW 73rd Ave., suite 110, Miami, FL 33155
099207 Medicis Dermatologics, Inc., 8125 North Hayden Rd., Scottsdale, AZ 85258.
[40 FR 13807, Mar. 27, 1975]
Editorial Notes:
1. For Federal Register citations affecting § 510.600, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.

2. At 72 FR 36595, July 5, 2007, § 510.600, in the table in paragraph (c)(2), was amended by removing the entry for “062749”; however, the amendment could not be incorporated because the entry did not exist.

3. At 77 FR 46613, Aug. 6, 2012, § 510.600 was amended by removing the entry for “012758” in the table in paragraph (c)(2); however, the amendment could not be incorporated because “012758” didn't exist.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


United States Code

Title 21 published on 2015-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 510 after this date.

  • 2015-12-09; vol. 80 # 236 - Wednesday, December 9, 2015
    1. 80 FR 76384 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawals of Approval of New Animal Drug Applications; Changes of Sponsorship
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendments.
      This rule is effective December 9, 2015, except for the amendments to 21 CFR 520.446, 520.2043, 558.625, and 558.630, which are effective December 21, 2015.
      21 CFR Parts 510, 520, 522, 524, and 558
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