21 C.F.R. § 510.600

Current through October 31, 2024

Section 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., 126 E Lincoln Ave., Rahway, NJ 07065	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
Aiping Pharmaceutical, Inc., 350W Wireless Blvd., Hauppauge, NY 11788	011788
Akorn Operating Co. LLC, 5605 Centerpoint Ct., Suite A, Gurnee, IL 60031	059399
Alexion Pharmaceuticals, Inc., 121 Seaport Blvd., Boston, MA 02210	069334
American Regent, Inc., Animal Health Division, Shirley, NY 11967	010797
Anika Therapeutics Inc., 236 West Cummings Park, Woburn, MA 01801	060865
Anivive Lifesciences, Inc., 3777 Worsham Ave., Long Beach, CA 90808	086121
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
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
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 Ballastiere, 33500 Libourne, France	013744
Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, County Galway, Ireland	061651
Cronus Pharma Specialities India Private Ltd., Plot No.9(B), Survey No. 99/1, GMR Hyderabad Aviation SEZ Ltd., Mamidipalle Village, Balapur Mandal, Shamshabad, Rangareddy, Hyderabad, Telangana, 500108, 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	017033
Diamond Animal Health, Inc., 2538 SE 43rd St., Des Moines, IA 50327	053701
Domes Pharma S.A., ZAC de Champ Lamet, 3 rue Andre Citroen, Pont-du-Chateau, Auvergne-Rhone-Alpes, 63430, FRANCE	086189
ECO LLC, 11224 Aurora Ave., Urbandale, IA 50322	066916
Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140	058198
Farnam Companies, Inc., 301 West Osborn, Phoenix, AZ 85013-3928	017135
Felix Pharmaceuticals Pvt. Ltd., 25-28 North Wall Quay, Dublin 1, Ireland	086101
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
Genus Lifesciences Inc., 700 N Fenwick St., Allentown, PA 18109	064950
GTC Biotherapeutics, Inc., 175 Crossing Blvd., Framingham, MA 01702	042976
Happy Jack, Inc., Snow Hill, NC 28580	023851
Hemoglobin Oxygen Therapeutics, LLC, 674 Souder Rd., Souderton, PA 18964	063075
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., 126 E Lincoln Ave., Rahway, NJ 07065	000061
Ishihara Sangyo Kaisha, Ltd., 3-15, Edobori 1-chome, Nishi-ku, Osaka 550-0002, Japan	064642
Ivaoes Animal Health, 2101 W Atlantic Blvd., Suite 108, Pompano Beach, FL 33069	086064
Jaguar Animal Health, 200 Pine St., Suite 600, San Francisco, CA 94104	086149
Kinetic Technologies, LLC, 961 Beasley St., suite 270, Lexington, KY 40509	051031
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, a Viatris Company, 3711 Collins Ferry Rd., Morgantown, WV 26505	063286
Natchez Animal Supply Co., 201 John R. Junkin Dr., Natchez, MS 39120	049968
Neogen Corp., 944 Nandino Blvd., Lexington, KY 40511	059051
Noble Pharma, LLC, 4602 Domain Dr., Menomonie, WI 54751	086119
Norbrook Laboratories Ltd., Carnbane Industrial Estate, Newry, County Down, BT35 6QQ, United Kingdom	055529
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 Pharma Ltd., Ground Floor, Piramal Ananta, Agastya Corporate Park, Mumbai, Maharashtra, 400070, India	065085
Planalquimica Industrial Ltda., Rua das Magnolias nr. 2405, Jardim das Bandeiras, CEP 13053-120, Campinas, Sao Paulo, Brazil	060728
Provetica LLC, 8735 Rosehill Rd., Suite 300, Lenexa, KS 66215	086097
Purina Animal Nutrition LLC, 4001 Lexington Ave., North Arden Hills, MN 55126-2910	017800
QBiotics Group Ltd., Suite 3A, Level 1, 165 Moggill Rd., Taringa, Queensland 4068, Australia	086132
Quo Vademus, LLC, 277 Faison McGowan Rd., Kenansville, NC 28349	076475
Revivicor, Inc., a wholly owned subsidiary of United Therapeutics Corp., 1700 Kraft Dr., Suite 2400, Blacksburg, VA 24060	086134
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
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
Vetoquinol N.-A., Inc., 2000 chemin Georges, Lavaltrie (PQ), Canada, J5T 3S5	059320
Vetoquinol USA, Inc., 4250 N Sylvania Ave., Fort Worth, TX 76137	017030
Virbac AH, Inc., PO Box 162059, Fort Worth, TX 76161	051311
Warburton Technology Ltd., 36 Fitzwilliam Square, Dublin 2, Dublin, D02HX82, Ireland	066679
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
ZyVet Animal Health, Inc., 73 Route 31N, Pennington, NJ 08534	086117

(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., 126 E Lincoln Ave., Rahway, NJ 07065
000115	IMPAX Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544.
010797	American Regent, Inc., Animal Health Division, Shirley, NY 11967.
011788	Aiping Pharmaceutical, Inc., 350W Wireless Blvd., Hauppauge, NY 11788.
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 Ballastiere, 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., 126 E Lincoln Ave., Rahway, NJ 07065.
017030	Vetoquinol USA, Inc., 4250 N. Sylvania Ave., Fort Worth, TX 76137.
017033	Dechra Veterinary Products LLC, 7015 College Blvd., Suite 525, Overland Park, KS 66211.
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 LLC, 4001 Lexington Ave., North Arden Hills, 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.
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.
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.
051672	Taro Pharmaceuticals U.S.A., Inc., 3 Skyline Dr., Hawthorne, NY 10532.
052483	Orion Corp., Orionintie 1, 02200 Espoo, Finland.
052923	Therio, Inc., 8801 Anderson Ave., Manhattan, KS 66503.
053701	Diamond Animal Health, Inc., 2538 SE 43rd St., Des Moines, IA 50327.
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., Carnbane Industrial Estate, Newry, County Down, BT35 6QQ, United Kingdom.
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	Vetoquinol N.-A., Inc., 2000 chemin Georges, Lavaltrie (PQ), Canada, J5T 3S5.
059399	Akorn Operating Co. LLC, 5605 Centerpoint Ct., Suite A, Gurnee, IL 60031.
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, a Viatris Company, 3711 Collins Ferry Rd., Morgantown, WV 26505.
064642	Ishihara Sangyo Kaisha, Ltd., 3-15, Edobori 1-chome, Nishi-ku, Osaka 550-0002, Japan.
064950	Genus Lifesciences Inc., 700 N Fenwick St., Allentown, PA 18109.
065085	Piramal Pharma Ltd., Ground Floor, Piramal Ananta, Agastya Corporate Park, Mumbai, Maharashtra, 400070, India.
066104	Phibro Animal Health Corp., GlenPointe Centre East, 3d floor, 300 Frank W. Burr Blvd., suite 21, Teaneck, NJ 07666.
066679	Warburton Technology Ltd., 36 Fitzwilliam Square, Dublin 2, Dublin, D02HX82, Ireland.
066916	ECO LLC, 11224 Aurora Ave., Urbandale, IA 50322.
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., Plot No.9(B), Survey No. 99/1, GMR Hyderabad Aviation SEZ Ltd., Mamidipalle Village, Balapur Mandal, Shamshabad, Rangareddy, Hyderabad, Telangana, 500108, India.
069254	Pharmgate Inc., 1800 Sir Tyler Dr., Wilmington, NC 28405.
069334	Alexion Pharmaceuticals, Inc., 121 Seaport Blvd., Boston, MA 02210.
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.
086053	AquaBounty Technologies, Inc., 2 Mill and Main Pl., Suite 395, Maynard, MA 01754.
086064	Ivaoes Animal Health, 2101 W Atlantic Blvd., Suite 108, Pompano Beach, FL 33069.
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.
086097	Provetica LLC, 8735 Rosehill Rd., Suite 300, Lenexa, KS 66215.
086101	Felix Pharmaceuticals Pvt. Ltd., 25-28 North Wall Quay, Dublin 1, Ireland.
086106	Union Agener, Inc., 1788 Lovers Ln., Augusta, GA 30901.
086113	Wildcat Feeds, 215 NE Strait Ave., Topeka, KS 66616.
086117	ZyVet Animal Health, Inc., 73 Route 31N, Pennington, NJ 08534.
086119	Noble Pharma, LLC, 4602 Domain Dr., Menomonie, WI 54751.
086121	Anivive Lifesciences, Inc., 3777 Worsham Ave., Long Beach, CA 90808.
086132	QBiotics Group Ltd., Suite 3A, Level 1, 165 Moggill Rd., Taringa, Queensland 4068, Australia.
086134	Revivicor, Inc., a wholly owned subsidiary of United Therapeutics Corp., 1700 Kraft Dr., Suite 2400, Blacksburg, VA 24060.
086149	Jaguar Animal Health, 200 Pine St., Suite 600, San Francisco, CA 94104.
086189	Domes Pharma S.A., ZAC de Champ Lamet, 3 rue Andre Citroen, Pont-du-Chateau, Auvergne-Rhone-Alpes, 63430, FRANCE.
099207	Bausch Health US, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807.

21 C.F.R. §510.600

40 FR 13807, Mar. 27, 1975

81 FR 3324, 1/21/2016; 81 FR 17606, 3/30/2016; 81 FR 36788, 6/8/2016; 81 FR 48702, 7/26/2016; 81 FR 59133, 8/29/2016; 81 FR 67151, 9/30/2016; 82 FR 11508, 2/24/2017; 82 FR 12169, 3/1/2017; 82 FR 12168, 3/13/2017; 82 FR 21690, 5/10/2017; 82 FR 43484, 9/18/2017; 82 FR 58555, 12/13/2017; 83 FR 13634, 3/30/2018; 83 FR 14586, 4/5/2018; 83 FR 48943, 9/28/2018; 83 FR 64739, 12/18/2018; 84 FR 8971, 3/13/2019; 84 FR 12493, 4/2/2019; 84 FR 39182, 8/9/2019; 84 FR 53310, 10/7/2019; 85 FR 4207, 1/24/2020; 85 FR 18118, 4/1/2020; 85 FR 45307, 7/28/2020; 86 FR 10819, 2/23/2021; 86 FR 13183, 3/8/2021; 86 FR 14817, 3/19/2021; 86 FR 17063, 4/1/2021; 86 FR 57995, 10/20/2021; 86 FR 61684, 11/8/2021; 87 FR 10966, 2/28/2022; 87 FR 17944, 3/29/2022; 87 FR 58960, 9/29/2022; 87 FR 76420, 12/14/2022; 88 FR 14896, 3/10/2023; 88 FR 16546, 3/20/2023; 88 FR 27697, 5/3/2023; 88 FR 55562, 8/16/2023; 88 FR 84698, 12/6/2023; 89 FR 14409, 2/27/2024; 89 FR 42356, 5/15/2024; 89 FR 85425 , 10/28/2024

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.