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Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 6 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS / PART 510 - NEW ANIMAL DRUGS / Subpart G - Sponsors of Approved Applications
Subpart G - 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.

(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 08527057699
Accord Healthcare, Inc., 1009 Slater Rd., suite 210-B, Durham, NC 27703016729
ADM Animal Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305-3115012286
Agri Laboratories, Ltd., P.O. Box 3103, St. Joseph, MO 64503057561
Agri-Tech, Inc., 4722 Broadway, Kansas City, MO 64112017762
Akorn Animal Health, Inc., 1925 West Field Ct., suite 300, Lake Forest, IL 60045059399
Alaco, Inc., 1500 North Wilmot Rd., suite 290-C, Tucson, AZ 85712064146
Alexion Pharmaceuticals, Inc., 100 College St., New Haven, CT 06510069334
American Pharmaceuticals and Cosmetics, Inc., 1401 Joel East Rd., Fort Worth, TX 76140065531
American Regent, Inc., Animal Health Division, Shirley, NY 11967010797
Anika Therapeutics Inc., 236 West Cummings Park, Woburn, MA 01801060865
Anzac Animal Health, LLC, 218 Millwell Dr., Suite B, Maryland Heights, MO 63043086073
AquaBounty Technologies, Inc., 2 Mill and Main Pl., Suite 395, Maynard, MA 01754086053
Aratana Therapeutics, Inc., 11400 Tomahawk Creek Pkwy., Leawood, KS 66211086026
Ark Sciences, Inc., 1101 East 33rd St., suite B304, Baltimore, MD 21218076175
Aurora Pharmaceutical, Inc., 1196 Highway 3 South, Northfield, MN 55057-3009051072
Axcentive SARL, Chemin de Champouse, Quartier Violesi, 13320 Bouc Bel Air, France086009
B.L. Mitchell, Inc., 103 Hwy. 82 E., Leland, MS 38756067188
Bausch Health US, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807099207
Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee Mission, KS 66201000859
Belcher Pharmaceuticals, LLC, 6911 Bryan Dairy Rd., Largo, FL 33777062250
Bimeda Animal Health Ltd., 1B The Herbert Building, The Park, Carrickmines, Dublin 18, Ireland061133
Boehringer Ingelheim Animal Health USA, Inc., 3239 Satellite Blvd., Duluth, GA 30096000010
Cephazone Pharma, LLC, 250 East Bonita Ave., Pomona, CA 91767068330
Ceva Sante Animale, 10 Avenue de la Ballastière, 33500 Libourne, France013744
Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, County Galway, Ireland061651
Cooperative Research Farms, Box 69, Charlotteville, NY 12036051267
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, India069043
Dechra, Ltd., Snaygill Industrial Estate, Keighley Rd., Skipton, North Yorkshire, BD23 2RW, United Kingdom043264
Dragon Fire Holding Co., Inc., 2619 Skyway Dr., Grand Prairie, TX 75052076033
ECO LLC, 344 Nassau St., Princeton, NJ 08540066916
Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140058198
Farnam Companies, Inc., 301 West Osborn, Phoenix, AZ 85013-3928017135
First Priority, Inc., 1590 Todd Farm Dr., Elgin, IL 60123058829
Fleming Laboratories, Inc., P.O. Box 34384, Charlotte, NC 28234015565
Fougera Pharmaceuticals, Inc., P.O. Box 2006, 60 Baylis Rd., Melville, NY 11747025463
G. C. Hanford Manufacturing Co., P.O. Box 1017, Syracuse, NY 13201010515
GTC Biotherapeutics, Inc., 175 Crossing Blvd., Framingham, MA 01702042976
Halocarbon Products Corp., 887 Kinderkamack Rd., River Edge, NJ 07661012164
Happy Jack, Inc., Snow Hill, NC 28580023851
Hemoglobin Oxygen Therapeutics, LLC, 674 Souder Rd., Souderton, PA 18964063075
Heska Corp., 1825 Sharp Point Dr., Fort Collins, CO 80525063604
Hikma International Pharmaceuticals LLC, P.O. Box 182400, Bayader Wadi Seer, Amman, Jordan 11118059115
HQ Specialty Pharma Corp., 120 Rte. 17 North, suite 130, Paramus, NJ 07652042791
Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sofia, Bulgaria016592
IMPAX Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544000115
Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940000061
Ivaoes Animal Health, 4300 SW 73rd Ave., suite 110, Miami, FL 33155086064
Jurox Pty. Ltd., 85 Gardiner St., Rutherford, NSW 2320, Australia049480
Kindred Biosciences, Inc., 1555 Bayshore Hwy., Suite 200, Burlingame, CA 94010086078
Kinetic Technologies, LLC, 961 Beasley St., suite 270, Lexington, KY 40509051031
LFB USA, Inc., 175 Crossing Blvd., Framingham, MA 01702086047
Lloyd, Inc., 604 W. Thomas Ave., Shenandoah, IA 51601061690
Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767-1861054925
Modern Veterinary Therapeutics, LLC, 14343 SW 119th Ave., Miami, FL 33186015914
Mylan Institutional, Inc., 12720 Dairy Ashford Rd., Sugar Land, TX 77478051079
Mylan Institutional LLC, 4901 Hiawatha Dr., Rockford, IL 61103063286
Natchez Animal Supply Co., 201 John R. Junkin Dr., Natchez, MS 39120049968
Neogen Corp., 944 Nandino Blvd., Lexington, KY 40511059051
Norbrook Laboratories, Ltd., Station Works, Newry BT35 6JP, Northern Ireland055529
Oasmia Pharmaceutical AB, Vallongatan 1, 75228 Uppsala, Sweden052818
Orion Corp., Orionintie 1, 02200 Espoo, Finland052483
OXIS International, Inc., 6040 N. Cutter Circle, suite 317, Portland, OR 97217-3935024991
Parnell Technologies Pty. Ltd., unit 4, 476 Gardeners Rd., Alexandria, New South Wales 2015, Australia068504
Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL 32514055246
Pharmaceutical Ventures, Ltd., P.O. Box D1400, Pomona, NY 10970050057
Pharmacosmos, Inc., 776 Mountain Blvd., Watchung, NJ 07069042552
Pharmaq AS, Skogmo Industriomrade, N-7863 Overhalla, Norway015331
Pharmgate, Inc., 1800 Sir Tyler Dr., Wilmington, NC 28405069254
Phibro Animal Health Corp., GlenPointe Centre East, 3d floor, 300 Frank W. Burr Blvd., suite 21, Teaneck, NJ 07666066104
Piramal Critical Care, Inc., 3850 Schelden Circle, Bethlehem, PA 18017066794
Piramal Enterprises Ltd., Ananta, Agastya Corporate Park, Opp Fire Brigade, Kamani Junction, LBS Mag Kurla (West), Mumbai, 400070, India065085
Planalquimica Industrial Ltda., Rua das Magnolias nr. 2405, Jardim das Bandeiras, CEP 13053-120, Campinas, Sao Paulo, Brazil060728
Purina Animal Nutrition LLC, 1080 County Road F West, Shoreview, MN 55126-2910017800
Putney, Inc., One Monument Sq., suite 400, Portland, ME 04101026637
Quo Vademus, LLC, 277 Faison McGowan Rd., Kenansville, NC 28349076475
Ridley USA, Inc., 111 W Cherry St., Suite 500, Mankato, MN 56001067949
RSR Laboratories, Inc., 501 Fifth St., Bristol, TN 37620058670
Sergeant's Pet Care Products, Inc., 10077 S. 134th St., Omaha, NE 68138021091
Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215058005
Squire Laboratories, Inc., 100 Mill St., Revere, MA 02151017153
Strategic Veterinary Pharmaceuticals, Inc., 100 NW. Airport Rd., St. Joseph, MO 64503054628
Summit Hill Laboratories, P.O. Box 535, Navesink, NJ 07752037990
Superior Equine Pharmaceuticals, Inc., Pleasant Grove, UT 84062027053
Syndel USA, 1441 W. Smith Rd., Ferndale, WA 98248050378
Taro Pharmaceuticals U.S.A., Inc., 3 Skyline Dr., Hawthorne, NY 10532051672
Therio, Inc., 8801 Anderson Ave., Manhattan, KS 66503052923
Thorn Bioscience LLC, 1044 East Chestnut St., Louisville, KY 40204051330
United-AH II LLC, 322 S Main St., Sheridan, IN 46069051233
VetDC, Inc., 320 E. Vine Dr., suite 218, Fort Collins, CO 80524086072
Vétoquinol N.-A., Inc., 2000 chemin Georges, Lavaltrie (PQ), Canada, J5T 3S5059320
Vétoquinol USA, Inc., 4250 N. Sylvania Ave., Fort Worth, TX 76137017030
Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137051311
Walco International, Inc., 15 West Putnam, Porterville, CA 93257049185
Wildlife Laboratories, Inc., 1230 W. Ash St., suite D, Windsor, CO 80550053923
Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007054771

(2) Numerical Listing of Sponsors

Drug labeler code Firm name and address
000010Boehringer Ingelheim Animal Health USA, Inc., 3239 Satellite Blvd., Duluth, GA 30096.
000061Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940.
000115IMPAX Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544.
000859Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee Mission, KS 66201.
010515G. C. Hanford Manufacturing Co., P.O. Box 1017, Syracuse, NY 13201.
010797American Regent, Inc., Animal Health Division, Shirley, NY 11967.
012164Halocarbon Products Corp., 887 Kinderkamack Rd., River Edge, NJ 07661.
012286ADM Animal Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305-3115.
012578Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Belgium.
013744Ceva Sante Animale, 10 Avenue de la Ballastière, 33500 Libourne, France.
015331Pharmaq AS, Skogmo Industriomrade, N-7863 Overhalla, Norway.
015565Fleming Laboratories, Inc., P.O. Box 34384, Charlotte, NC 28234.
015914Modern Veterinary Therapeutics, LLC, 14343 SW 119th Ave., Miami, FL 33186.
016592Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sofia, Bulgaria.
016729Accord Healthcare, Inc., 1009 Slater Rd., suite 210-B, Durham, NC 27703.
017030Vétoquinol USA, Inc., 4250 N. Sylvania Ave., Fort Worth, TX 76137.
017135Farnam Companies, Inc., 301 West Osborn, Phoenix, AZ 85013-3928.
017153Squire Laboratories, Inc., 100 Mill St., Revere, MA 02151.
017762Agri-Tech, Inc., 4722 Broadway, Kansas City, MO 64112.
017800Purina Animal Nutrition, 1080 County Road F West, Shoreview, MN 55126-2910.
021091Sergeant's Pet Care Products, Inc., 10077 S. 134th St., Omaha, NE 68138.
023851Happy Jack, Inc., Snow Hill, NC 28580.
024991OXIS International, Inc., 6040 N. Cutter Circle, suite 317 Portland, OR 97217-3935.
025463Fougera Pharmaceuticals, Inc., P.O. Box 2006, 60 Baylis Rd., Melville, NY 11747.
026637Putney, Inc., One Monument Sq., suite 400, Portland, ME 04101.
027053Superior Equine Pharmaceuticals, Inc., Pleasant Grove, UT 84062.
037990Summit Hill Laboratories, P.O. Box 535, Navesink, NJ 07752.
042552Pharmacosmos, Inc., 776 Mountain Blvd., Watchung, NJ 07069.
042791HQ Specialty Pharma Corp., 120 Rte. 17 North, suite 130, Paramus, NJ 07652.
042976GTC Biotherapeutics, Inc., 175 Crossing Blvd., Framingham, MA 01702.
043264Dechra, Ltd., Snaygill Industrial Estate, Keighley Rd., Skipton, North Yorkshire, BD23 2RW, United Kingdom.
049185Walco International, Inc., 15 West Putnam, Porterville, CA 93257.
049480Jurox Pty. Ltd., 85 Gardiner St., Rutherford, NSW 2320, Australia.
049968Natchez Animal Supply Co., 201 John R. Junkin Dr., Natchez, MS 39120.
050057Pharmaceutical Ventures, Ltd., P.O. Box D1400, Pomona, NY 10970.
050378Syndel USA, 1441 W. Smith Rd., Ferndale, WA 98248.
051031Kinetic Technologies, LLC, 961 Beasley St., suite 270, Lexington, KY 40509.
051072Aurora Pharmaceutical, Inc., 1196 Highway 3 South, Northfield, MN 55057-3009.
051079Mylan Institutional, Inc., 12720 Dairy Ashford Rd., Sugar Land, TX 77478.
051233United-AH II LLC, 322 S Main St., Sheridan, IN 46069.
051267Cooperative Research Farms, Box 69, Charlotteville, NY 12036.
051311Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137.
051330Thorn Bioscience LLC, 1044 East Chestnut St., Louisville, KY 40204.
051672Taro Pharmaceuticals U.S.A., Inc., 3 Skyline Dr., Hawthorne, NY 10532.
052483Orion Corp., Orionintie 1, 02200 Espoo, Finland.
052818Oasmia Pharmaceutical AB, Vallongatan 1, 75228 Uppsala, Sweden.
052923Therio, Inc., 8801 Anderson Ave., Manhattan, KS 66503.
053923Wildlife Laboratories, Inc., 1230 W. Ash St., suite D, Windsor, CO 80550.
054628Strategic Veterinary Pharmaceuticals, Inc., 100 NW. Airport Rd., St. Joseph, MO 64503.
054771Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007.
054925Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767-1861.
055246Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL 32514.
055529Norbrook Laboratories, Ltd., Station Works, Newry BT35 6JP, Northern Ireland.
057561Agri Laboratories, Ltd., P.O. Box 3103, St. Joseph, MO 64503.
057699A & G Pharmaceuticals, Inc., 1030 West Commodore Blvd., Jackson, NJ 08527.
058005Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215.
058198Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140.
058670RSR Laboratories, Inc., 501 Fifth St., Bristol, TN 37620.
058829First Priority, Inc., 1590 Todd Farm Dr., Elgin, IL 60123.
059051Neogen Corp., 944 Nandino Blvd., Lexington, KY 40511.
059115Hikma International Pharmaceuticals LLC, P.O. Box 182400, Bayader Wadi Seer, Amman, Jordan 11118.
059320Vétoquinol N.-A., Inc., 2000 chemin Georges, Lavaltrie (PQ), Canada, J5T 3S5.
059399Akorn Animal Health, Inc., 1925 West Field Ct., suite 300, Lake Forest, IL 60045.
060728Planalquimica Industrial Ltda., Rua das Magnolias nr. Jardim das Bandeiras, CEP 13053-120, Campinas, Sao Alto, Brazil.
060865Anika Therapeutics Inc., 236 West Cummings Park, Woburn, MA 01801.
061133Bimeda Animal Health Ltd., 1B The Herbert Building, The Park, Carrickmines, Dublin 18, Ireland.
061651Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, County Galway, Ireland.
061690Lloyd, Inc., 604 W. Thomas Ave., Shenandoah, IA 51601.
062250Belcher Pharmaceuticals, LLC, 6911 Bryan Dairy Rd., Largo, FL 33777.
062794Mylan Bertek Pharmaceuticals, Inc., 12720 Dairy Ashford, Sugar Land, TX 77478.
063075Hemoglobin Oxygen Therapeutics, LLC, 674 Souder Rd., Souderton, PA 18964.
063286Mylan Institutional, LLC, 4901 Hiawatha Dr., Rockford, IL 61103.
063604Heska Corp., 1825 Sharp Point Dr., Fort Collins, CO 80525.
064146Alaco, Inc., 1500 North Wilmot Rd., suite 290-C, Tucson, AZ 85712.
065085Piramal Enterprises Ltd., Ananta, Agastya Corporate Park, Opp Fire Brigade, Kamani Junction, LBS Mag Kurla (West), Mumbai, 400070, India.
065531American Pharmaceuticals and Cosmetics, Inc., 1401 Joel East Rd., Fort Worth, TX 76140.
066104Phibro Animal Health Corp., GlenPointe Centre East, 3d floor, 300 Frank W. Burr Blvd., suite 21, Teaneck, NJ 07666.
066794Piramal Critical Care, Inc., 3850 Schelden Circle, Bethlehem, PA 18017.
066916ECO LLC, 344 Nassau St., Princeton, NJ 08540.
067188B.L. Mitchell, Inc., 103 Hwy. 82 E., Leland, MS 38756.
067949Ridley USA, Inc., 111 W Cherry St., Suite 500, Mankato, MN 56001.
068330Cephazone Pharma, LLC, 250 East Bonita Ave., Pomona, CA 91767.
068504Parnell Technologies Pty. Ltd., unit 4, 476 Gardeners Rd., Alexandria, New South Wales 2015, Australia.
069043Cronus 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.
069254Pharmgate, Inc., 1800 Sir Tyler Dr., Wilmington, NC 28405.
069334Alexion Pharmaceuticals, Inc., 100 College St., New Haven, CT 06510.
076033Dragon Fire Holding Co., Inc., 2619 Skyway Dr., Grand Prairie, TX 75052.
076175Ark Sciences, Inc., 1101 East 33rd St., suite B304, Baltimore, MD 21218.
076475Quo Vademus, LLC, 277 Faison McGowan Rd., Kenansville, NC 28349.
086009Axcentive SARL, Chemin de Champouse, Quartier Violesi, 13320 Bouc Bel Air, France.
086026Aratana Therapeutics, Inc., 11400 Tomahawk Creek Pkwy., Leawood, KS 66211.
086047LFB USA, Inc., 175 Crossing Blvd., Framingham, MA 01702.
086053AquaBounty Technologies, Inc., 2 Mill and Main Pl., Suite 395, Maynard, MA 01754.
086064Ivaoes Animal Health, 4300 SW 73rd Ave., suite 110, Miami, FL 33155.
086072VetDC, Inc., 320 E Vine Dr., suite 218, Fort Collins, CO 80524.
086073Anzac Animal Health, LLC, 218 Millwell Dr., Suite B, Maryland Heights, MO 63043.
086078Kindred Biosciences, Inc., 1555 Bayshore Hwy., Suite 200, Burlingame, CA 94010.
099207Bausch 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.
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