21 CFR § 510.600
Names, addresses, and drug labeler codes of sponsors of approved applications
June 25, 2020
(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
Open Table
| 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 Animal 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 |
| Alexion Pharmaceuticals, Inc., 100 College St., New Haven, CT 06510 | 069334 |
| American Regent, Inc., Animal Health Division, Shirley, NY 11967 | 010797 |
| Anika Therapeutics Inc., 236 West Cummings Park, Woburn, MA 01801 | 060865 |
| Anzac Animal Health, LLC, 218 Millwell Dr., Suite B, Maryland Heights, MO 63043 | 086073 |
| AquaBounty Technologies, Inc., 2 Mill and Main Pl., Suite 395, Maynard, MA 01754 | 086053 |
| Ark Sciences, Inc., 1101 East 33rd St., suite B304, Baltimore, MD 21218 | 076175 |
| Aurora Pharmaceutical, Inc., 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 |
| Bausch Health US, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807 | 099207 |
| 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 |
| Bimeda Animal Health Ltd., 1B The Herbert Building, The Park, Carrickmines, Dublin 18, Ireland | 061133 |
| Boehringer Ingelheim Animal Health USA, Inc., 3239 Satellite Blvd., Duluth, GA 30096 | 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 |
| Cronus Pharma Specialities India Private Ltd., Sy No: 99/1, M/s GMR Hyderabad Aviation SEZ L, Mamidipalli Village, Shamshabad Mandal, Ranga, Hyderabad, Telangana, 501218, India | 069043 |
| Dechra, Ltd., Snaygill Industrial Estate, Keighley Rd., Skipton, North Yorkshire, BD23 2RW, United Kingdom | 043264 |
| Dechra Veterinary Products LLC, 7015 College Blvd., Suite 525, Overland Park, KS 66211 | 026637 |
| ECO LLC, 344 Nassau St., Princeton, NJ 08540 | 066916 |
| 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 |
| 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., 6525 The Corners Pkwy., Suite 200, Peachtree Corners, GA 30092 | 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 |
| 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 |
| 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 |
| Jurox Pty. Ltd., 85 Gardiner St., Rutherford, NSW 2320, Australia | 049480 |
| Kindred Biosciences, Inc., 1555 Bayshore Hwy., Suite 200, Burlingame, CA 94010 | 086078 |
| Kinetic Technologies, LLC, 961 Beasley St., suite 270, Lexington, KY 40509 | 051031 |
| LFB USA, Inc., 175 Crossing Blvd., Framingham, MA 01702 | 086047 |
| Lloyd, Inc., 604 W. Thomas Ave., Shenandoah, IA 51601 | 061690 |
| Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767-1861 | 054925 |
| Mizner Bioscience LLC, 225 NE Mizner Blvd., Suite 760, Boca Raton, FL 33432 | 086039 |
| Modern Veterinary Therapeutics, LLC, 14343 SW 119th Ave., Miami, FL 33186 | 015914 |
| 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 |
| 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, Inc., 1800 Sir Tyler Dr., 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 Enterprises Ltd., Ananta, Agastya Corporate Park, Opp Fire Brigade, Kamani Junction, LBS Mag Kurla (West), Mumbai, 400070, 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 |
| Quo Vademus, LLC, 277 Faison McGowan Rd., Kenansville, NC 28349 | 076475 |
| Ridley USA, Inc., 111 W Cherry St., Suite 500, Mankato, MN 56001 | 067949 |
| RSR Laboratories, Inc., 501 Fifth St., Bristol, TN 37620 | 058670 |
| Sergeant's Pet Care Products, Inc., 10077 S. 134th St., Omaha, NE 68138 | 021091 |
| Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215 | 058005 |
| Squire Laboratories, Inc., 100 Mill St., Revere, MA 02151 | 017153 |
| Summit Hill Laboratories, P.O. Box 535, Navesink, NJ 07752 | 037990 |
| Superior Equine Pharmaceuticals, Inc., Pleasant Grove, UT 84062 | 027053 |
| Syndel USA, 1441 W. Smith Rd., Ferndale, WA 98248 | 050378 |
| 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 |
| Union Agener, Inc., 1788 Lovers Ln., Augusta, GA 30901 | 086106 |
| United-AH II LLC, 322 S Main St., Sheridan, IN 46069 | 051233 |
| VetDC, Inc., 320 E. Vine Dr., suite 218, Fort Collins, CO 80524 | 086072 |
| 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., PO Box 162059, Fort Worth, TX 76161 | 051311 |
| Walco International, Inc., 15 West Putnam, Porterville, CA 93257 | 049185 |
| Wildcat Feeds, 215 NE Strait Ave., Topeka, KS 66616 | 086113 |
| Wildlife Laboratories, Inc., 1230 W. Ash St., suite D, Windsor, CO 80550 | 053923 |
| Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 | 054771 |
(2) Numerical Listing of Sponsors
Open Table
| Drug labeler code | Firm name and address |
|---|---|
| 000010 | Boehringer Ingelheim Animal Health USA, Inc., 3239 Satellite Blvd., Duluth, GA 30096. |
| 000061 | Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940. |
| 000115 | IMPAX Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544. |
| 000859 | Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee Mission, KS 66201. |
| 010515 | G. C. Hanford Manufacturing Co., P.O. Box 1017, Syracuse, NY 13201. |
| 010797 | American Regent, Inc., Animal Health Division, Shirley, NY 11967. |
| 012164 | Halocarbon Products Corp., 6525 The Corners Pkwy., Suite 200, Peachtree Corners, GA 30092. |
| 012286 | ADM Animal 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. |
| 015914 | Modern Veterinary Therapeutics, LLC, 14343 SW 119th Ave., Miami, FL 33186. |
| 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 | Sergeant's Pet Care Products, Inc., 10077 S. 134th St., Omaha, NE 68138. |
| 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 | Dechra Veterinary Products LLC, 7015 College Blvd., Suite 525, Overland Park, KS 66211. |
| 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 | Syndel USA, 1441 W. Smith Rd., Ferndale, WA 98248. |
| 051031 | Kinetic Technologies, LLC, 961 Beasley St., suite 270, Lexington, KY 40509. |
| 051072 | Aurora Pharmaceutical, Inc., 1196 Highway 3 South, Northfield, MN 55057-3009. |
| 051079 | Mylan Institutional, Inc., 12720 Dairy Ashford Rd., Sugar Land, TX 77478. |
| 051233 | United-AH II LLC, 322 S Main St., Sheridan, IN 46069. |
| 051311 | Virbac AH, Inc., PO Box 162059, Fort Worth, TX 76161. |
| 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., 1230 W. Ash St., suite D, Windsor, CO 80550. |
| 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. |
| 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. |
| 061133 | Bimeda Animal Health Ltd., 1B The Herbert Building, The Park, Carrickmines, Dublin 18, 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. |
| 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 Enterprises Ltd., Ananta, Agastya Corporate Park, Opp Fire Brigade, Kamani Junction, LBS Mag Kurla (West), Mumbai, 400070, India. |
| 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 USA, Inc., 111 W Cherry St., Suite 500, Mankato, MN 56001. |
| 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 Specialities India Private Ltd., Sy No: 99/1, M/s GMR Hyderabad Aviation SEZ L, Mamidipalli Village, Shamshabad Mandal, Ranga, Hyderabad, Telangana, 501218, India. |
| 069254 | Pharmgate, Inc., 1800 Sir Tyler Dr., Wilmington, NC 28405. |
| 069334 | Alexion Pharmaceuticals, Inc., 100 College St., New Haven, CT 06510. |
| 076175 | Ark Sciences, Inc., 1101 East 33rd St., suite B304, Baltimore, MD 21218. |
| 076475 | Quo Vademus, LLC, 277 Faison McGowan Rd., Kenansville, NC 28349. |
| 086009 | Axcentive SARL, Chemin de Champouse, Quartier Violesi, 13320 Bouc Bel Air, France. |
| 086039 | Mizner Bioscience LLC, 225 NE Mizner Blvd., Suite 760, Boca Raton, FL 33432. |
| 086047 | LFB USA, Inc., 175 Crossing Blvd., Framingham, MA 01702. |
| 086053 | AquaBounty Technologies, Inc., 2 Mill and Main Pl., Suite 395, Maynard, MA 01754. |
| 086064 | Ivaoes Animal Health, 4300 SW 73rd Ave., suite 110, Miami, FL 33155. |
| 086072 | VetDC, Inc., 320 E Vine Dr., suite 218, Fort Collins, CO 80524. |
| 086073 | Anzac Animal Health, LLC, 218 Millwell Dr., Suite B, Maryland Heights, MO 63043. |
| 086078 | Kindred Biosciences, Inc., 1555 Bayshore Hwy., Suite 200, Burlingame, CA 94010. |
| 086106 | Union Agener, Inc., 1788 Lovers Ln., Augusta, GA 30901. |
| 086113 | Wildcat Feeds, 215 NE Strait Ave., Topeka, KS 66616. |
| 099207 | Bausch Health US, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807. |
[40 FR 13807, Mar. 27, 1975]
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