(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------------------------------------------------------------------------
Drug labeler
Firm name and address code------------------------------------------------------------------------A & G Pharmaceuticals, Inc., 1030 West Commodore Blvd., 057699
Jackson, NJ 08527......................................AB Science, 3 Avenue George V, 75008 Paris, France...... 052913Abbott Laboratories, North Chicago, IL 60064............ 000044Accord Healthcare, Inc., 1009 Slater Rd., suite 210-B, 016729
Durham, NC 27703.......................................ADM Alliance Nutrition, Inc., 1000 North 30th St., 012286
Quincy, IL 62305-3115..................................Agri Laboratories, Ltd., P.O. Box 3103, St. Joseph, MO 057561
64503..................................................Agri-Tech, Inc., 4722 Broadway, Kansas City, MO 64112... 017762Akorn Animal Health, Inc., 1925 West Field Ct., suite 059399
300, Lake Forest, IL 60045.............................Alaco, Inc., 1500 North Wilmot Rd., suite 290-C, Tucson, 064146
AZ 85712...............................................American Pharmaceuticals and Cosmetics, Inc., 1401 Joel 065531
East Rd., Fort Worth, TX 76140.........................Anika Therapeutics Inc., 236 West Cummings Park, Woburn, 060865
MA 01801...............................................Ark Sciences, Inc., 1101 East 33rd St., suite B304, 076175
Baltimore, MD 21218....................................Aurora Pharmaceutical, LLC, 1196 Highway 3 South, 051072
Northfield, MN 55057-3009..............................Axcentive SARL, Chemin de Champouse, Quartier Violesi, 086009
13320 Bouc Bel Air, France.............................B.L. Mitchell, Inc., 103 Hwy. 82 E., Leland, MS 38756... 067188Baxter Healthcare Corp., One Baxter Pkwy., Deerfield, IL 010019
60015..................................................Bayer HealthCare LLC, Animal Health Division, P.O. Box 000859
390, Shawnee Mission, KS 66201.........................Belcher Pharmaceuticals, LLC, 6911 Bryan Dairy Rd., 062250
Largo, FL 33777........................................Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt 000010
Highway, St. Joseph, MO 64506-2002.....................Cephazone Pharma, LLC, 250 East Bonita Ave., Pomona, CA 068330
91767..................................................Ceva Sante Animale, 10 Avenue de la Ballasti[egrave]re, 013744
33500 Libourne, France.................................Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, 061651
County Galway, Ireland.................................ConAgra Pet Products Co., 3902 Leavenworth St., Omaha, 021091
NE 68105...............................................Contemporary Products, Inc., 3788 Elm Springs Rd., 055462
Springdale, AR 72764-6067..............................Cooperative Research Farms, Box 69, Charlotteville, NY 051267
12036..................................................Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, 061623
Dublin 24, Ireland.....................................Dechra, Ltd., Snaygill Industrial Estate, Keighley Rd., 043264
Skipton, North Yorkshire, BD23 2RW, United Kingdom.....ECO LLC, 344 Nassau St., Princeton, NJ 08540............ 066916Elanco Animal Health, A Division of Eli Lilly & Co., 000986
Lilly Corporate Center, Indianapolis, IN 46285.........Farnam Companies, Inc., 301 West Osborn, Phoenix, AZ 017135
85013-3928.............................................First Priority, Inc., 1590 Todd Farm Dr., Elgin, IL 058829
60123..................................................Fleming Laboratories, Inc., P.O. Box 34384, Charlotte, 015565
NC 28234...............................................Fougera Pharmaceuticals, Inc., P.O. Box 2006, 60 Baylis 025463
Rd., Melville, NY 11747................................G. C. Hanford Manufacturing Co., P.O. Box 1017, 010515
Syracuse, NY 13201.....................................GTC Biotherapeutics, Inc., 175 Crossing Blvd., 042976
Framingham, MA 01702...................................Halocarbon Products Corp., 887 Kinderkamack Rd., River 012164
Edge, NJ 07661.........................................Happy Jack, Inc., Snow Hill, NC 28580................... 023851Heska Corp., 1825 Sharp Point Dr., Fort Collins, CO 063604
80525..................................................Hikma International Pharmaceuticals LLC, P.O. Box 059115
182400, Bayader Wadi Seer, Amman, Jordan 11118.........Hospira, Inc., 275 North Field Dr., Lake Forest, IL 000409
60045..................................................HQ Specialty Pharma Corp., 120 Rte. 17 North, Suite 130, 042791
Paramus, NJ 07652......................................Huvepharma AD, 5th Floor, 3A Nikolay Haytov Str., 1113 016592
Sofia, Bulgaria........................................IDEXX Pharmaceuticals, Inc., 7009 Albert Pick Rd., 065274
Greensboro, NC 27409...................................IMPAX Laboratories, Inc., 30831 Huntwood Ave., Hayward, 000115
CA 94544...............................................International Nutrition, Inc., 7706 `I' Plaza, Omaha, NE 043733
68127..................................................Intervet, Inc., 556 Morris Ave., Summit, NJ 07901....... 000061JBS United Animal Health II LLC, 322 S. Main St., 051233
Sheridan, IN 46069.....................................Jurox Pty. Ltd., 85 Gardiner St., Rutherford, NSW 2320, 049480
Australia..............................................Lloyd, Inc., 604 W. Thomas Ave., Shenandoah, IA 51601... 061690Luitpold Pharmaceuticals, Inc., Animal Health Division, 010797
Shirley, NY 11967......................................Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 054925
91767-1861.............................................Medicis Dermatologics, Inc., 8125 North Hayden Rd., 099207
Scottsdale, AZ 85258...................................Merial Ltd., 3239 Satellite Blvd., Bldg. 500, Duluth, GA 050604
30096-4640.............................................Mylan Institutional, Inc., 12720 Dairy Ashford Rd., 051079
Sugar Land, TX 77478...................................Mylan Institutional LLC, 4901 Hiawatha Dr., Rockford, IL 063286
61103..................................................Natchez Animal Supply Co., 201 John R. Junkin Dr., 049968
Natchez, MS 39120......................................Neogen Corp., 944 Nandino Blvd., Lexington, KY 40511.... 059051Nexcyon Pharmaceuticals, Inc., 644 West Washington Ave., 050929
Madison, WI 53719......................................Norbrook Laboratories, Ltd., Station Works, Newry BT35 055529
6JP, Northern Ireland..................................Novartis Animal Health US, Inc., 3200 Northline Ave., 058198
suite 300, Greensboro, NC 27408........................NutriBasics Co., North Highway 71, P.O. Box 1014, 053740
WIllmar, MN 56201......................................Oasmia Pharmaceutical AB, Vallongatan 1, 75228 Uppsala, 052818
Sweden.................................................Orion Corp., Orionintie 1, 02200 Espoo, Finland......... 052483OPK Biotech, LLC, 11 and 39 Hurley St., Cambridge, MA 063075
02141..................................................OXIS International, Inc., 6040 N. Cutter Circle, Suite 024991
317, Portland, OR 97217-3935...........................Paladin Labs (USA), Inc., 160 Greentree Dr., suite 101, 046129
Dover, DE 19904........................................Parnell Technologies Pty. Ltd., unit 4, 476 Gardeners 068504
Rd., Alexandria, New South Wales 2015, Australia.......Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL 055246
32514..................................................
Pharmaceutical Ventures, Ltd., P.O. Box D1400, Pomona, 050057
NY 10970...............................................Pharmacosmos, Inc., 776 Mountain Blvd., Watchung, NJ 042552
07069..................................................Pharmaq AS, Skogmo Industriomrade, N-7863 Overhalla, 015331
Norway.................................................Pharmgate LLC, 161 North Franklin Turnpike, suite 2C, 069254
Ramsey, NJ 07446.......................................Phibro Animal Health Corp., GlenPointe Centre East, 3d 066104
floor, 300 Frank W. Burr Blvd., suite 21, Teaneck, NJ
07666..................................................Piramal Critical Care, Inc., 3850 Schelden Circle, 066794
Bethlehem, PA 18017....................................Piramal Healthcare Ltd., Piramal Tower, Ganpatrao Kadam 065085
Marg, Lower Parel, Mumbai - 400 013, India.............Planalquimica Industrial Ltda., Rua das Magnolias nr. 060728
2405, Jardim das Bandeiras, CEP 13053-120, Campinas,
Sao Paulo, Brazil......................................Purina Animal Nutrition LLC, 1080 County Road F West, 017800
Shoreview, MN 55126-2910...............................Putney, Inc., One Monument Sq., Suite 400, Portland, ME 026637
04101..................................................Quo Vademus, LLC, 277 Faison McGowan Rd., Kenansville, 076475
NC 28349...............................................Ridley Block Operations Inc., 424 North Riverfront Dr., 068287
P.O. Box 8500, Mankato, MN 56002-8500..................Ridley U.S. Holdings, Inc., 424 North Riverfront Dr., 067949
P.O. Box 8500, Mankato, MN 56002-8500..................RSR Laboratories, Inc., 501 Fifth St., Bristol, TN 37620 058670Seeco Inc., Box 1014, North Highway 71, Willmar, MN 011749
56201..................................................Sioux Biochemical, Inc., 204 Third St. NW., Sioux 063112
Center, IA 51250.......................................SmartVet USA, Inc., 22201 West Innovation Dr., Suite 086001
170A, Olathe, KS 66061-1304............................Sogeval S.A., 200 Avenue de Mayenne, 53000 Laval, France 059120Southern Micro-Blenders, Inc., 3801 North Hawthorne St., 049685
Chattanooga, TN 37406..................................Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., 058005
Lenexa, KS 66215.......................................Squire Laboratories, Inc., 100 Mill St., Revere, MA 017153
02151..................................................Strategic Veterinary Pharmaceuticals, Inc., 100 NW. 054628
Airport Rd., St. Joseph, MO 64503......................Summit Hill Laboratories, P.O. Box 535, Navesink, NJ 037990
07752..................................................Superior Equine Pharmaceuticals, Inc., Pleasant Grove, 027053
UT 84062...............................................Taro Pharmaceuticals U.S.A., Inc., 3 Skyline Dr., 051672
Hawthorne, NY 10532....................................Teva Canada Ltd., 30 Novopharm Ct., Toronto, Ontario, 043806
Canada M1B 2K9.........................................Therio, Inc., 8801 Anderson Ave., Manhattan, KS 66503... 052923Thorn Bioscience LLC, 1044 East Chestnut St., 051330
Louisville, KY 40204...................................V[eacute]toquinol N.-A., Inc., 2000 chemin Georges, 059320
Lavaltrie (PQ), Canada, J5T 3S5........................V[eacute]toquinol USA, Inc., 4250 N. Sylvania Ave., Fort 017030
Worth, TX 76137........................................Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137 051311Walco International, Inc., 15 West Putnam, Porterville, 049185
CA 93257Watson Laboratories, Inc., 311 Bonnie Circle, Corona, CA 000402
92880..................................................Wellmark International, 1501 East Woodfield Rd., suite 011536
200 West, Schaumburg, IL 60173.........................Western Chemical, Inc., 1269 Lattimore Rd., Ferndale, WA 050378
98248..................................................Wildlife Laboratories, Inc., 1401 Duff Dr., Suite 600, 053923
Fort Collins, CO 80524.................................Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007....... 054771------------------------------------------------------------------------
(2) Numerical Listing of Sponsors------------------------------------------------------------------------
Drug labeler
code Firm name and address------------------------------------------------------------------------
000010 Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt
Highway, St. Joseph, MO 64506-2002.
000044 Abbott Laboratories, North Chicago, IL 60064.
000061 Intervet, Inc., 556 Morris Ave., Summit, NJ 07901.
000115 IMPAX Laboratories, Inc., 30831 Huntwood Ave., Hayward,
CA 94544.
000402 Watson Laboratories, Inc., 311 Bonnie Circle, Corona, CA
92880.
000409 Hospira Inc., 275 North Field Dr., Lake Forest, IL
60045.
000859 Bayer HealthCare LLC, Animal Health Division, P.O. Box
390, Shawnee Mission, KS 66201.
000986 Elanco Animal Health, A Division of Eli Lilly & Co.,
Lilly Corporate Center, Indianapolis, IN 46285.
010019 Baxter Healthcare Corp., One Baxter Pkwy., Deerfield, IL
60015.
010515 G. C. Hanford Manufacturing Co., P.O. Box 1017,
Syracuse, NY 13201.
010797 Luitpold Pharmaceuticals, Inc., Animal Health Division,
Shirley, NY 11967.
011536 Wellmark International, 1501 East Woodfield Rd., suite
200 West, Schaumburg, IL 60173.
012164 Halocarbon Products Corp., 887 Kinderkamack Rd., River
Edge, NJ 07661.
012286 ADM Alliance 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 Ballasti[egrave]re,
33500 Libourne, France.
015331 Pharmaq AS, Skogmo Industriomrade, N-7863 Overhalla,
Norway.
015565 Fleming Laboratories, Inc., P.O. Box 34384, Charlotte,
NC 28234.
016592 Huvepharma AD, 5th Floor, 3A Nikolay Haytov Str., 1113
Sofia, Bulgaria.
016729 Accord Healthcare, Inc., 1009 Slater Rd., suite 210-B,
Durham, NC 27703.
017030 V[eacute]toquinol 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 ConAgra Pet Products Co., 3902 Leavenworth St., Omaha,
NE 68105.
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 Putney, Inc., One Monument Sq., Suite 400, Portland, ME
04101.
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.
043733 International Nutrition, Inc., 7706 `I' Plaza, Omaha, NE
68127.
043806 Teva Canada Ltd., 30 Novopharm Ct., Toronto, Ontario,
Canada M1B 2K9.
046129 Paladin Labs (USA), Inc., 160 Greentree Dr., suite 101,
Dover, DE 19904.
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 Western Chemical, Inc., 1269 Lattimore Rd., Ferndale, WA
98248.
050604 Merial Ltd., 3239 Satellite Blvd., Bldg. 500, Duluth, GA
30096-4640.
050929 Nexcyon Pharmaceuticals, Inc., 644 West Washington Ave.,
Madison, WI 53719.
051072 Aurora Pharmaceutical, LLC, 1196 Highway 3 South,
Northfield, MN 55057-3009.
051079 Mylan Institutional, Inc., 12720 Dairy Ashford Rd.,
Sugar Land, TX 77478.
051233 JBS United Animal Health II LLC, 322 S. Main St.,
Sheridan, IN 46069.
051267 Cooperative Research Farms, Box 69, Charlotteville, NY
12036.
051311 Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX
76137.
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.
052913 AB Science, 3 Avenue George V, 75008 Paris, France.
052923 Therio, Inc., 8801 Anderson Ave., Manhattan, KS 66503.
053923 Wildlife Laboratories, Inc., 1401 Duff Dr., Suite 600,
Fort Collins, CO 80524.
054628 Strategic Veterinary Pharmaceuticals, Inc., 100 NW.
Airport Rd., St. Joseph, MO 64503.
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.
055462 Contemporary Products, Inc., 3788 Elm Springs Rd.,
Springdale, AR 72764-6067.
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 Novartis Animal Health US, Inc., 3200 Northline Ave.,
suite 300, Greensboro, NC 27408.
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.
059120 Sogeval S.A., 200 Avenue de Mayenne, 53000 Laval,
France.
059320 V[eacute]toquinol 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.
061623 Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght,
Dublin 24, 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 OPK Biotech, LLC, 11 and 39 Hurley St., Cambridge, MA
02141.
063112 Sioux Biochemical, Inc., 204 Third St. NW., Sioux
Center, IA 51250.
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 Healthcare Ltd., Piramal Tower, Ganpatrao Kadam
Marg, Lower Parel, Mumbai - 400 013, India.
065274 IDEXX Pharmaceuticals, Inc., 7009 Albert Pick Rd.,
Greensboro, NC 27409.
065531 American Pharmaceuticals and Cosmetics, Inc., 1401 Joel
East Rd., Fort Worth, TX 76140.
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 U.S. Holdings, Inc., 424 N. Riverfront Dr., P.O.
Box 8500, Mankato, MN 56002-8500.
068287 Ridley Block Operations Inc., 424 North Riverfront Dr.,
P.O. Box 8500, Mankato, MN 56002-8500.
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.
069254 Pharmgate LLC, 161 North Franklin Turnpike, suite 2C,
Ramsey, NJ 07446
076175 Ark Sciences, Inc., 1101 East 33rd St., suite B304,
Baltimore, MD 21218.
076475 Quo Vademus, LLC, 277 Faison McGowan Rd., Kenansville,
NC 28349.
086001 SmartVet USA, Inc., 22201 West Innovation Dr., Suite
170A, Olathe, KS 66061-1304.
086009 Axcentive SARL, Chemin de Champouse, Quartier Violesi,
13320 Bouc Bel Air, France.
099207 Medicis Dermatologics, Inc., 8125 North Hayden Rd.,
Scottsdale, AZ 85258.------------------------------------------------------------------------ [40 FR 13807, Mar. 27, 1975]
Editorial Notes: 1. For Federal Register citations affecting Sec. 510.600, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.
2. At 72 FR 36595, July 5, 2007, Sec. 510.600, in the table in paragraph (c)(2), was amended by removing the entry for ``062749''; however, the amendment could not be incorporated because the entry does not exist.
3. At 77 FR 46613, Aug. 6, 2012, Sec. 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'' doesn't exist.