Title 21

SECTION 510.600

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

§ 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.

(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 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
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
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
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
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
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

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.
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.
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.
058829	First Priority, Inc., 1590 Todd Farm Dr., Elgin, IL 60123.
059051	Neogen Corp., 944 Nandino Blvd., Lexington, KY 40511.
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.
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] 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.govinfo.gov.

2. 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.