1. Regulations
  2. title 21
  3. chapter I-i5
  4. part 510
  5. subpart G
  6. § 510.600

View all text of Subpart G [§ 510.600 - § 510.600]

§ 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., 126 E Lincoln Ave., Rahway, NJ 07065016729 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 Aiping Pharmaceutical, Inc., 350W Wireless Blvd., Hauppauge, NY 11788011788 Akorn Operating Co. LLC, 5605 Centerpoint Ct., Suite A, Gurnee, IL 60031059399 Alexion Pharmaceuticals, Inc., 121 Seaport Blvd., Boston, MA 02210069334 American Regent, Inc., Animal Health Division, Shirley, NY 11967010797 Anika Therapeutics Inc., 236 West Cummings Park, Woburn, MA 01801060865 Anivive Lifesciences, Inc., 3777 Worsham Ave., Long Beach, CA 90808086121 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 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 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 Cronus Pharma Specialities India Private Ltd., Sy No-99/1, M/s GMR Hyderabad Aviation SEZ Ltd., Mamidipalli Village, Shamshabad Mandal, Ranga Reddy, Hyderabad, Telangana, 501218, India069043 Dechra, Ltd., Snaygill Industrial Estate, Keighley Rd., Skipton, North Yorkshire, BD23 2RW, United Kingdom043264 Dechra Veterinary Products LLC, 7015 College Blvd., Suite 525, Overland Park, KS 66211017033 Domes Pharma S.A., ZAC de Champ Lamet, 3 rue Andre Citroen, Pont-du-Chateau, Auvergne-Rhône-Alpes, 63430, FRANCE086189 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 Felix Pharmaceuticals Pvt. Ltd., 25-28 North Wall Quay, Dublin 1, Ireland086101 First Priority, Inc., 1590 Todd Farm Dr., Elgin, IL 60123058829 Fougera Pharmaceuticals, Inc., P.O. Box 2006, 60 Baylis Rd., Melville, NY 11747025463 Genus Lifesciences Inc., 700 N Fenwick St., Allentown, PA 18109064950 GTC Biotherapeutics, Inc., 175 Crossing Blvd., Framingham, MA 01702042976 Happy Jack, Inc., Snow Hill, NC 28580023851 Hemoglobin Oxygen Therapeutics, LLC, 674 Souder Rd., Souderton, PA 18964063075 Heska Corp., 3760 Rocky Mountain Ave., Loveland, CO 80538-7084063604 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., 126 E Lincoln Ave., Rahway, NJ 07065000061 Ishihara Sangyo Kaisha, Ltd., 3-15, Edobori 1-chome, Nishi-ku, Osaka 550-0002, Japan064642 Ivaoes Animal Health, 4300 SW 73rd Ave., Suite 110, Miami, FL 33155086064 Jaguar Animal Health, 200 Pine St., Suite 600, San Francisco, CA 94104086149 Kinetic Technologies, LLC, 961 Beasley St., suite 270, Lexington, KY 40509051031 Lloyd, Inc., 604 W. Thomas Ave., Shenandoah, IA 51601061690 Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767-1861054925 Mizner Bioscience LLC, 225 NE Mizner Blvd., Suite 760, Boca Raton, FL 33432086039 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, a Viatris Company, 3711 Collins Ferry Rd., Morgantown, WV 26505063286 Natchez Animal Supply Co., 201 John R. Junkin Dr., Natchez, MS 39120049968 Neogen Corp., 944 Nandino Blvd., Lexington, KY 40511059051 Noble Pharma, LLC, 4602 Domain Dr., Menomonie, WI 54751086119 Norbrook Laboratories Ltd., Carnbane Industrial Estate, Newry, County Down, BT35 6QQ, United Kingdom055529 Orion Corp., Orionintie 1, 02200 Espoo, Finland052483 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 Pharma Ltd., Ground Floor, Piramal Ananta, Agastya Corporate Park, Mumbai, Maharashtra, 400070, India065085 Planalquimica Industrial Ltda., Rua das Magnolias nr. 2405, Jardim das Bandeiras, CEP 13053-120, Campinas, Sao Paulo, Brazil060728 Provetica LLC, 8735 Rosehill Rd., Suite 300, Lenexa, KS 66215086097 Purina Animal Nutrition LLC, 4001 Lexington Ave., North Arden Hills, MN 55126-2910017800 QBiotics Group Ltd., Suite 3A, Level 1, 165 Moggill Rd., Taringa, Queensland 4068, Australia086132 Quo Vademus, LLC, 277 Faison McGowan Rd., Kenansville, NC 28349076475 Revivicor, Inc., a wholly owned subsidiary of United Therapeutics Corp., 1700 Kraft Dr., Suite 2400, Blacksburg, VA 24060086134 Ridley USA, Inc., 111 W Cherry St., Suite 500, Mankato, MN 56001067949 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 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 Union Agener, Inc., 1788 Lovers Ln., Augusta, GA 30901086106 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 Vetoquinol USA, Inc., 4250 N Sylvania Ave., Fort Worth, TX 76137017030 Virbac AH, Inc., PO Box 162059, Fort Worth, TX 76161051311 Wildcat Feeds, 215 NE Strait Ave., Topeka, KS 66616086113 Wildlife Laboratories, Inc., 1230 W. Ash St., suite D, Windsor, CO 80550053923 Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007054771 ZyVet Animal Health, Inc., 73 Route 31N, Pennington, NJ 08534086117

(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., 126 E Lincoln Ave., Rahway, NJ 07065 000115IMPAX Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544. 010797American Regent, Inc., Animal Health Division, Shirley, NY 11967. 011788Aiping Pharmaceutical, Inc., 350W Wireless Blvd., Hauppauge, NY 11788. 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. 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., 126 E Lincoln Ave., Rahway, NJ 07065. 017030Vetoquinol USA, Inc., 4250 N. Sylvania Ave., Fort Worth, TX 76137. 017033Dechra Veterinary Products LLC, 7015 College Blvd., Suite 525, Overland Park, KS 66211. 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 LLC, 4001 Lexington Ave., North Arden Hills, MN 55126-2910. 021091Sergeant's Pet Care Products, Inc., 10077 S. 134th St., Omaha, NE 68138. 023851Happy Jack, Inc., Snow Hill, NC 28580. 025463Fougera Pharmaceuticals, Inc., P.O. Box 2006, 60 Baylis Rd., Melville, NY 11747. 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. 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. 051311Virbac AH, Inc., PO Box 162059, Fort Worth, TX 76161. 051672Taro Pharmaceuticals U.S.A., Inc., 3 Skyline Dr., Hawthorne, NY 10532. 052483Orion Corp., Orionintie 1, 02200 Espoo, Finland. 052923Therio, Inc., 8801 Anderson Ave., Manhattan, KS 66503. 053923Wildlife Laboratories, Inc., 1230 W. Ash St., suite D, Windsor, CO 80550. 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., Carnbane Industrial Estate, Newry, County Down, BT35 6QQ, United Kingdom. 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. 058829First Priority, Inc., 1590 Todd Farm Dr., Elgin, IL 60123. 059051Neogen Corp., 944 Nandino Blvd., Lexington, KY 40511. 059320Vétoquinol N.-A., Inc., 2000 chemin Georges, Lavaltrie (PQ), Canada, J5T 3S5. 059399Akorn Operating Co. LLC, 5605 Centerpoint Ct., Suite A, Gurnee, IL 60031. 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, a Viatris Company, 3711 Collins Ferry Rd., Morgantown, WV 26505. 063604Heska Corp., 3760 Rocky Mountain Ave., Loveland, CO 80538-7084. 064642Ishihara Sangyo Kaisha, Ltd., 3-15, Edobori 1-chome, Nishi-ku, Osaka 550-0002, Japan. 064950Genus Lifesciences Inc., 700 N Fenwick St., Allentown, PA 18109. 065085Piramal Pharma Ltd., Ground Floor, Piramal Ananta, Agastya Corporate Park, Mumbai, Maharashtra, 400070, India. 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 Ltd., Mamidipalli Village, Shamshabad Mandal, Ranga Reddy, Hyderabad, Telangana, 501218, India. 069254Pharmgate Inc., 1800 Sir Tyler Dr., Wilmington, NC 28405. 069334Alexion Pharmaceuticals, Inc., 121 Seaport Blvd., Boston, MA 02210. 076475Quo Vademus, LLC, 277 Faison McGowan Rd., Kenansville, NC 28349. 086009Axcentive SARL, Chemin de Champouse, Quartier Violesi, 13320 Bouc Bel Air, France. 086039Mizner Bioscience LLC, 225 NE Mizner Blvd., Suite 760, Boca Raton, FL 33432. 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. 086097Provetica LLC, 8735 Rosehill Rd., Suite 300, Lenexa, KS 66215. 086101Felix Pharmaceuticals Pvt. Ltd., 25-28 North Wall Quay, Dublin 1, Ireland. 086106Union Agener, Inc., 1788 Lovers Ln., Augusta, GA 30901. 086113Wildcat Feeds, 215 NE Strait Ave., Topeka, KS 66616. 086117ZyVet Animal Health, Inc., 73 Route 31N, Pennington, NJ 08534. 086119Noble Pharma, LLC, 4602 Domain Dr., Menomonie, WI 54751. 086121Anivive Lifesciences, Inc., 3777 Worsham Ave., Long Beach, CA 90808. 086132QBiotics Group Ltd., Suite 3A, Level 1, 165 Moggill Rd., Taringa, Queensland 4068, Australia. 086134Revivicor, Inc., a wholly owned subsidiary of United Therapeutics Corp., 1700 Kraft Dr., Suite 2400, Blacksburg, VA 24060. 086149Jaguar Animal Health, 200 Pine St., Suite 600, San Francisco, CA 94104. 086189Domes Pharma S.A., ZAC de Champ Lamet, 3 rue Andre Citroen, Pont-du-Chateau, Auvergne-Rhône-Alpes, 63430, FRANCE. 099207Bausch Health US, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807.
[40 FR 13807, Mar. 27, 1975] Editorial Note: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.

AUTHORITY: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

SOURCE: 40 FR 13807, Mar. 27, 1975, unless otherwise noted.

CITE AS: 21 CFR 510.600