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  5. List of Medically Important Antimicrobial Drugs Affected by GFI #213
  1. Antimicrobial Resistance

List of Medically Important Antimicrobial Drugs Affected by GFI #213

Type of Application Application Number Sponsor Ingredient(s) Action(s)
Pioneer 006-084 Huvepharma EOOD Sulfamethazine Supplemental application approved to change to veterinary oversight*
Pioneer 006-391 Huvepharma EOOD Sulfaquinoxaline Supplemental application approved to change to veterinary oversight*
Pioneer 006-677 Huvepharma EOOD Sulfaquinoxaline Supplemental application approved to change to veterinary oversight*
Pioneer 006-707 Zoetis Inc. Sulfaquinoxaline Supplemental application approved to change to veterinary oversight*
Pioneer 006-891 Huvepharma EOOD Sulfaquinoxaline Supplemental application approved to change to veterinary oversight*
Pioneer 007-076 Cross Vetpharm Group Ltd. Sulfaquinoxaline Application Voluntarily Withdrawn
(81 FR 36790, June 8, 2016;
81 FR 36787, June 8, 2016)
Pioneer 007-087 Huvepharma EOOD Sulfaquinoxaline Supplemental application approved to change to veterinary oversight*
Pioneer 008-244 Cross Vetpharm Group Ltd. Sulfaquinoxaline Application Voluntarily Withdrawn
(81 FR 36790, June 8, 2016;
81 FR 36787, June 8, 2016)
Pioneer 008-622 Zoetis Inc. Oxytetracycline Supplemental application approved to change to veterinary oversight*
Pioneer 008-804 Phibro Animal Health Corp. Oxytetracycline Supplemental application approved to remove production indication and change to veterinary oversight*
Pioneer 010-092 Cross Vetpharm Group Ltd. Erythromycin Supplemental application approved to remove production indication and change to veterinary oversight*
Pioneer 010-918 Elanco US, Inc. Hygromycin B Supplemental application approved to change to veterinary oversight*
Pioneer 011-315 Zoetis Inc. Neomycin Supplemental application approved to change to veterinary oversight*
Pioneer 012-491 Elanco US, Inc. Tylosin Supplemental application approved to remove production indication and change to veterinary oversight*
Pioneer 013-076 Elanco US, Inc. Tylosin Veterinary Oversight
(79 FR 37617, July 2, 2014)
Pioneer 013-162 Elanco US, Inc. Tylosin Application Voluntarily Withdrawn
(81 FR 59131, August 29, 2016;
81 FR 59135, August 29, 2016)
Pioneer 013-214 Virbac AH, Inc. Hygromycin B Application Voluntarily Withdrawn
(79 FR 19814, April 10, 2014;
79 FR 19816, April 10, 2014)
Pioneer 015-160 Zoetis Inc. Sulfachloropyrazine Supplemental application approved to change to veterinary oversight*
Pioneer 015-166 Elanco US, Inc. Tylosin Application Voluntarily Withdrawn
(81 FR 59131, August 29, 2016;
81 FR 59135, August 29, 2016)
Pioneer 031-205 Zoetis Inc. Sulfadimethoxine Supplemental application approved to change to veterinary oversight*
Pioneer 031-553 Zoetis Inc. Sulfachloropyrazine Supplemental application approved to change to veterinary oversight*
Pioneer 032-946 Zoetis Inc. Carbomycin, Oxytetracycline Supplemental application approved to change to veterinary oversight*
Pioneer 033-373 Huvepharma EOOD Sulfachlorpyridazine Supplemental application approved to change to veterinary oversight*
Pioneer 033-950 Zoetis Inc. Sulfamerazine Supplemental application approved to change to veterinary oversight*
Pioneer 034-085 Zoetis Inc. Lincomycin Sponsor has requested withdrawal of approval*
Pioneer 035-157 Cross Vetpharm Group Ltd. Erythromycin Supplemental application approved to change to veterinary oversight*
Pioneer 035-287 Phibro Animal Health Corp. Oleandomycin Sponsor has requested withdrawal of approval*
Pioneer 035-688 Zoetis Inc. Chlortetracycline, Sulfamethazine Supplemental application approved to change to veterinary oversight*;  Reformulated without penicillin; production indications withdrawn.
(79 FR 37621, July 2, 2014;
79 FR 37622, July 2, 2014) 
Pioneer 035-805 Zoetis Inc. Chlortetracycline, Sulfamethazine Supplemental application approved to change to veterinary oversight*
Pioneer 038-200 Phibro Animal Health Corp. Oxytetracycline Supplemental application approved to change to veterinary oversight*
Pioneer 038-241 Cross Vetpharm Group Ltd. Arsanilic Acid, Erythromycin, Zoalene Application Voluntarily Withdrawn
(79 FR 10974, February 27, 2014;
79 FR 10976, February 27, 2014)
Pioneer 038-242 Cross Vetpharm Group Ltd. Amprolium, Arsanilic Acid, Erythromycin, Ethopabate Application Voluntarily Withdrawn
(79 FR 10974, February 27, 2014;
79 FR 10976, February 27, 2014)
Pioneer 038-439 Phibro Animal Health Corp. Oxytetracycline Supplemental application approved to change to veterinary oversight*
Pioneer 038-624 Cross Vetpharm Group Ltd. Arsanilic Acid, Erythromycin Application Voluntarily Withdrawn
(79 FR 10974, February 27, 2014;
79 FR 10976, February 27, 2014)
Pioneer 038-661 Cross Vetpharm Group Ltd. Spectinomycin Supplemental application approved to remove production indication and change to veterinary oversight*
Pioneer 039-077 Zoetis Inc. Chlortetracycline, Penicillin, Sulfathiazole Application Voluntarily Withdrawn
(79 FR 15540, March 20, 2014;
79 FR 15441, March 20, 2014)
Pioneer 040-209 Zoetis Inc. Ormetoprim, Sulfadimethoxine Supplemental application approved to change to veterinary oversight*
Pioneer 041-275 Elanco US, Inc. Tylosin, Sulfamethazine Supplemental application approved to change to veterinary oversight*
Pioneer 041-647 Zoetis Inc. Chlortetracycline, Sulfamethazine Supplemental application approved to change to veterinary oversight*
Pioneer 041-648 Zoetis Inc. Chlortetracycline, Sulfamethazine Supplemental application approved to change to veterinary oversight*
Pioneer 041-649 Zoetis Inc. Chlortetracycline, Sulfamethazine Supplemental application approved to change to veterinary oversight*
Pioneer 041-650 Zoetis Inc. Chlortetracycline, Sulfamethazine Supplemental application approved to change to veterinary oversight*
Pioneer 041-651 Zoetis Inc. Chlortetracycline, Sulfamethazine Supplemental application approved to change to veterinary oversight*
Pioneer 041-652 Zoetis Inc. Chlortetracycline, Sulfamethazine Supplemental application approved to change to veterinary oversight*
Pioneer 041-653 Zoetis Inc. Chlortetracycline, Sulfamethazine Supplemental application approved to change to veterinary oversight*
Pioneer 041-654 Zoetis Inc. Chlortetracycline, Sulfamethazine Supplemental application approved to change to veterinary oversight*
Pioneer 041-955 Cross Vetpharm Group Ltd. Erythromycin Application Voluntarily Withdrawn
(81 FR 36790, June 8, 2016;
81 FR 36787, June 8, 2016)
Pioneer 042-660 Virbac AH, Inc. Sulfamethazine, Tylosin Application Voluntarily Withdrawn
(79 FR 19814, April 10, 2014;
79 FR 19816, April 10, 2014)
Pioneer 043-387 Virbac AH, Inc. Tylosin Application Voluntarily Withdrawn
(79 FR 19814, April 10, 2014;
79 FR 19816, April 10, 2014)
Pioneer 046-109 Zoetis Inc. Lincomycin, Spectinomycin Supplemental application approved to change to veterinary oversight*
Pioneer 046-285 Zoetis Inc. Sulfadimethoxine Supplemental application approved to change to veterinary oversight*
Pioneer 046-415 Zoetis Inc. Tylosin Supplemental application approved to remove production indication and change to veterinary oversight*
Pioneer 046-666 Zoetis Inc. Penicillin Application Voluntarily Withdrawn
(80 FR 61293, October 13, 2015;
 80 FR 61298, October 13, 2015)
Pioneer 046-668 Phibro Animal Health Corp. Penicillin Sponsor has requested withdrawal of approval*
Pioneer 046-699 Zoetis Inc. Chlortetracycline Supplemental application approved to remove production indication and change to veterinary oversight*
Pioneer 048-480 Pharmgate LLC Chlortetracycline Supplemental application approved to remove production indication and change to veterinary oversight*
Pioneer 048-761 Zoetis Inc. Chlortetracycline Supplemental application approved to remove production indication and change to veterinary oversight*
Pioneer 049-287 Zoetis Inc. Chlortetracycline Supplemental application approved to remove production indication and change to veterinary oversight*
Pioneer 049-729 Cross Vetpharm Group Ltd. Sulfamethazine Application Voluntarily Withdrawn
(81 FR 36790, June 8, 2016;
81 FR 36787, June 8, 2016)
Pioneer 055-012 Huvepharma EOOD Chlortetracycline, Sulfamethazine Supplemental application approved to change to veterinary oversight*
Pioneer 055-020 Zoetis Inc. Chlortetracycline Supplemental application approved to change to veterinary oversight*
Pioneer 055-060 Zoetis Inc. Penicillin Supplemental application approved to change to veterinary oversight*
Pioneer 065-071 Huvepharma EOOD Chlortetracycline Supplemental application approved to change to veterinary oversight*
Pioneer 065-123 Zoetis Inc. Tetracycline Supplemental application approved to change to veterinary oversight*
Pioneer  065-140 Huvepharma EOOD Tetracycline Supplemental application approved to change to veterinary oversight*
Pioneer 065-178 Phibro Animal Health Corp. Chlortetracycline Supplemental application approved to change to veterinary oversight*
Pioneer 065-252 Huvepharma EOOD Streptomycin Veterinary Oversight
(80 FR 61293, October 13, 2015)
Pioneer 065-256 Pharmgate LLC Chlortetracycline Supplemental application approved to change to veterinary oversight*
Pioneer 065-269 Huvepharma AD Tetracycline Supplemental application approved to change to veterinary oversight*
Pioneer 065-410 Zoetis Inc. Tetracycline Supplemental application approved to change to veterinary oversight*
Pioneer 065-440 Huvepharma EOOD Chlortetracycline Supplemental application approved to change to veterinary oversight*
Pioneer 065-441 Zoetis Inc. Tetracycline Supplemental application approved to change to veterinary oversight*
Pioneer 065-480 Pharmgate LLC Chlortetracycline Supplemental application approved to change to veterinary oversight*
Pioneer 065-486 Strategic Veterinary Pharmaceuticals, Inc. Chlortetracycline Supplemental application approved to change to veterinary oversight*
Pioneer 065-496 Phibro Animal Health Corp. Tetracycline Supplemental application approved to change to veterinary oversight*
Pioneer 091-191 Intervet, Inc. Gentamicin Supplemental application approved to change to veterinary oversight*
Pioneer 091-467 Phibro Animal Health Corp. Virginiamycin Supplemental application approved to remove production indication and change to veterinary oversight*
Pioneer 091-513 Phibro Animal Health Corp. Virginiamycin Sponsor has requested withdrawal of approval*
Pioneer 091-582 ADM Alliance Nutrition, Inc. Tylosin Application Voluntarily Withdrawn
(79 FR 19814, April 10, 2014;
79 FR 19816, April 10, 2014)
Pioneer 091-668 Zoetis Inc. Chlortetracycline, Penicillin, Sulfamethazine Sponsor has requested withdrawal of approval*
Pioneer 091-749 Zoetis Inc. Sulfamethazine, Tylosin Supplemental application approved to change to veterinary oversight*
Pioneer 092-286 Phibro Animal Health Corp. Chlortetracycline Supplemental application approved to remove production indication and change to veterinary oversight*
Pioneer 092-287 Phibro Animal Health Corp. Chlortetracycline Supplemental application approved to remove production indication and change to veterinary oversight*
Pioneer 094-975 Phibro Animal Health Corp. Neomycin, Oxytetracycline Supplemental application approved to remove production indication and change to veterinary oversight*
Pioneer 095-143 Phibro Animal Health Corp. Oxytetracycline Supplemental application approved to remove production indication and change to veterinary oversight*
Pioneer 097-505 Zoetis Inc. Lincomycin Supplemental application approved to remove production indication and change to veterinary oversight*
Pioneer 098-431 Phibro Animal Health Corp. Tylosin Supplemental application approved to remove production indication and change to veterinary oversight*
Pioneer 099-468 Ridley USA Inc. Tylosin Application Voluntarily Withdrawn
(79 FR 19814, April 10, 2014;
79 FR 19816, April 10, 2014)
Pioneer 099-767 Virbac AH, Inc. Sulfamethazine, Tylosin Application Voluntarily Withdrawn
(79 FR 19814, April 10, 2014;
79 FR 19816, April 10, 2014)
Pioneer 100-094 Huvepharma EOOD Sulfamerazine, Sulfamethazine, Sulfaquinoxaline Supplemental application approved to change to veterinary oversight*
Pioneer 100-128 Cross Vetpharm Group Ltd. Tylosin Application Voluntarily Withdrawn
(81 FR 36790, June 8, 2016;
81 FR 36787, June 8, 2016)
Pioneer 100-901 Zoetis Inc. Chlortetracycline Supplemental application approved to remove production indication and change to veterinary oversight*
Pioneer 106-964 Elanco US, Inc. Apramycin Supplemental application approved to change to veterinary oversight*
Pioneer 108-484 ADM Alliance Nutrition, Inc. Sulfamethazine, Tylosin Application Voluntarily Withdrawn
(79 FR 19814, April 10, 2014;
79 FR 19816, April 10, 2014)
Pioneer 110-045 ADM Alliance Nutrition, Inc. Tylosin Application Voluntarily Withdrawn
(79 FR 19814, April 10, 2014;
79 FR 19816, April 10, 2014)
Pioneer 110-439 ADM Alliance Nutrition, Inc. Hygromycin B Application Voluntarily Withdrawn
(79 FR 19814, April 10, 2014;
79 FR 19816, April 10, 2014)
Pioneer 111-636 Zoetis Inc. Lincomycin Supplemental application approved to change to veterinary oversight*
Pioneer 122-272 Huvepharma EOOD Sulfamethazine Supplemental application approved to change to veterinary oversight*
Pioneer 125-933 Pharmaq AS Ormetoprim, Sulfadimethoxine Supplemental application approved to change to veterinary oversight*
Pioneer 126-050 Elanco US, Inc. Apramycin Supplemental application approved to change to veterinary oversight*
Pioneer 127-507 Elanco US, Inc. Sulfamethazine, Tylosin Application Voluntarily Withdrawn
(81 FR 59131, August 29, 2016;
81 FR 59135, August 29, 2016)
Pioneer 128-411 ADM Alliance Nutrition, Inc. Sulfamethazine, Tylosin Application Voluntarily Withdrawn
(79 FR 19814, April 10, 2014;
79 FR 19816, April 10, 2014)
Pioneer 130-435 Huvepharma EOOD Oxytetracycline Supplemental application approved to change to veterinary oversight*
Pioneer 131-958 Ridley USA Inc. Sulfamethazine, Tylosin Application Voluntarily Withdrawn
(79 FR 19814, April 10, 2014;
79 FR 19816, April 10, 2014)
Pioneer 132-574 Virbac AH, Inc. Lincomycin Application Voluntarily Withdrawn
(79 FR 19814, April 10, 2014;
79 FR 19816, April 10, 2014)
Pioneer 133-334 Zoetis Inc. Virginiamycin Sponsor has requested withdrawal of approval*
Pioneer 133-836 Intervet, Inc. Gentamicin Supplemental application approved to change to veterinary oversight*
Pioneer 138-187 Micro Beef Technologies LTD Tylosin Application Voluntarily Withdrawn
(79 FR 19814, April 10, 2014;
79 FR 19816, April 10, 2014)
Pioneer 138-934 Pharmgate LLC Chlortetracycline, Sulfamethazine Supplemental application approved to change to veterinary oversight*; Reformulated without penicillin, production indications withdrawn
Pioneer 138-935 Pharmgate LLC Chlortetracycline Supplemental application approved to remove production indication and change to veterinary oversight*
Pioneer 138-938 Pharmgate LLC Oxytetracycline Supplemental application approved to remove production indication and change to veterinary oversight*
Pioneer 138-939 Pharmgate LLC Neomycin, Oxytetracycline Supplemental application approved to remove production indication and change to veterinary oversight*
Pioneer 140-443 Zoetis Inc. Hygromycin B Sponsor has requested withdrawal of approval*
Pioneer 140-578 Zoetis Inc. Tetracycline Supplemental application approved to change to veterinary oversight*
Pioneer 140-680 Pharmgate LLC Tylosin Application Voluntarily Withdrawn
(80 FR 76384, December 9, 2015;
80 FR 76387, December 9, 2015)
Pioneer 140-681 Pharmgate LLC Sulfamethazine, Tylosin Application Voluntarily Withdrawn
(80 FR 76384, December 9, 2015;
80 FR 76387, December 9, 2015)
Pioneer 140-976 Zoetis Inc. Neomycin Supplemental application approved to change to veterinary oversight*
Pioneer 140-998 Phibro Animal Health Corp. Virginiamycin Supplemental application approved to remove production indication and change to veterinary oversight*
Generic 200-026 Pharmgate LLC Oxytetracycline Supplemental application approved to change to veterinary oversight*
Generic 200-030 Agri Laboratories, Ltd. Sulfadimethoxine Supplemental application approved to change to veterinary oversight*
Generic 200-031 Agri Laboratories, Ltd. Sulfadimethoxine Supplemental application approved to change to veterinary oversight*
Generic 200-046 Zoetis Inc. Neomycin Supplemental application approved to change to veterinary oversight*
Generic 200-049 Agri Laboratories, Ltd. Tetracycline Supplemental application approved to change to veterinary oversight*
Generic 200-050 Cross Vetpharm Group Ltd. Neomycin Supplemental application approved to change to veterinary oversight*
Generic 200-066 Agri Laboratories, Ltd. Oxytetracycline Supplemental application approved to change to veterinary oversight*
Generic 200-103 Cross Vetpharm Group Ltd. Penicillin Supplemental application approved to change to veterinary oversight*
Generic 200-106 Huvepharma EOOD Penicillin Supplemental application approved to change to veterinary oversight*
Generic 200-113 Zoetis Inc. Neomycin Supplemental application approved to change to veterinary oversight*
Generic 200-118 Huvepharma EOOD Neomycin Supplemental application approved to change to veterinary oversight*
Generic 200-122 Zoetis Inc. Penicillin Supplemental application approved to change to veterinary oversight*
Generic 200-130 Huvepharma EOOD Neomycin Supplemental application approved to change to veterinary oversight*
Generic 200-136 Quo Vademus, LLC Tetracycline Supplemental application approved to change to veterinary oversight*
Generic 200-140 Zoetis Inc. Chlortetracycline, Penicillin, Sulfathiazole Application Voluntarily Withdrawn
(79 FR 15540, March 20, 2014;
79 FR 15441, March 20, 2014)
Generic 200-144 Cross Vetpharm Group Ltd. Oxytetracycline Supplemental application approved to change to veterinary oversight*
Generic 200-146 Cross Vetpharm Group Ltd. Oxytetracycline Supplemental application approved to change to veterinary oversight*
Generic 200-153 Huvepharma EOOD Neomycin Supplemental application approved to change to veterinary oversight*
Generic 200-165 Strategic Veterinary Pharmaceuticals, Inc. Sulfadimethoxine Supplemental application approved to change to veterinary oversight*
Generic 200-167 Zoetis Inc. Chlortetracycline, Penicillin, Sulfathiazole Application Voluntarily Withdrawn
(79 FR 15540, March 20, 2014;
79 FR 15441, March 20, 2014)
Generic 200-185 Agri Laboratories, Ltd. Gentamicin Supplemental application approved to change to veterinary oversight*
Generic 200-189 Huvepharma EOOD Lincomycin Supplemental application approved to change to veterinary oversight*
Generic 200-190 Med-Pharmex, Inc. Gentamicin Supplemental application approved to change to veterinary oversight*
Generic 200-192 Huvepharma EOOD Sulfadimethoxine Supplemental application approved to change to veterinary oversight*
Generic 200-197 Huvepharma EOOD Streptomycin Supplemental application approved to change to veterinary oversight*
Generic 200-233 Zoetis Inc. Lincomycin Supplemental application approved to change to veterinary oversight*
Generic 200-234 Med-Pharmex, Inc. Tetracycline Supplemental application approved to change to veterinary oversight*
Generic 200-235 Med-Pharmex, Inc. Neomycin Supplemental application approved to change to veterinary oversight*
Generic 200-236 Quo Vademus, LLC Chlortetracycline Supplemental application approved to change to veterinary oversight*
Generic 200-238 Med-Pharmex, Inc. Sulfadimethoxine Supplemental application approved to change to veterinary oversight*
Generic 200-241 Med-Pharmex, Inc. Lincomycin Supplemental application approved to change to veterinary oversight*
Generic 200-247 Cross Vetpharm Group Ltd. Oxytetracycline Supplemental application approved to change to veterinary oversight*
Generic 200-251 Med-Pharmex, Inc. Sulfadimethoxine Supplemental application approved to change to veterinary oversight*
Generic 200-258 Phibro Animal Health Corp. Sulfadimethoxine Supplemental application approved to change to veterinary oversight*
Generic 200-289 Med-Pharmex, Inc. Neomycin Supplemental application approved to change to veterinary oversight*
Generic 200-295 Pharmgate LLC Chlortetracycline Supplemental application approved to change to veterinary oversight*
Generic 200-303 Quo Vademus, LLC Lincomycin Supplemental application approved to change to veterinary oversight*
Generic 200-305 Vetoquinol N.-A., Inc. Oxytetracycline Application Voluntarily Withdrawn
(79 FR 74021, December 15, 2014;
79 FR 74018, December 15, 2014)
Generic 200-307 Vetoquinol N.-A., Inc. Penicillin Application Voluntarily Withdrawn
(81 FR 36790, June 8, 2016;
81 FR 36787, June 8, 2016)
Generic 200-314 Pharmgate LLC Chlortetracycline, Sulfamethazine Supplemental application approved to change to veterinary oversight*
Generic 200-345 Phibro Animal Health Corp. Lincomycin, Spectinomycin Supplemental application approved to change to veterinary oversight*
Generic 200-347 Quo Vademus, LLC Penicillin Supplemental application approved to change to veterinary oversight*
Generic 200-372 G.C. Hanford Manufacturing Co. Penicillin Supplemental application approved to change to veterinary oversight*
Generic 200-374 Cross Vetpharm Group Ltd. Tetracycline Supplemental application approved to change to veterinary oversight*
Generic 200-376 Cross Vetpharm Group Ltd. Sulfadimethoxine Supplemental application approved to change to veterinary oversight*
Generic 200-377 Cross Vetpharm Group Ltd. Lincomycin Supplemental application approved to change to veterinary oversight*
Generic 200-378 Sparhawk Laboratories, Inc. Neomycin Supplemental application approved to change to veterinary oversight*
Generic 200-379 Sparhawk Laboratories, Inc. Neomycin Supplemental application approved to change to veterinary oversight*
Generic 200-380 Cross Vetpharm Group Ltd. Lincomycin, Spectinomycin Supplemental application approved to change to veterinary oversight*
Generic 200-407 Agri Laboratories, Ltd. Lincomycin, Spectinomycin Supplemental application approved to change to veterinary oversight*
Generic 200-434 Cross Vetpharm Group Ltd. Sulfamethazine Supplemental application approved to change to veterinary oversight*
Generic 200-441 Huvepharma EOOD Chlortetracycline Supplemental application approved to change to veterinary oversight*
Generic 200-443 First Priority, Inc. Sulfadimethoxine Supplemental application approved to change to veterinary oversight*
Generic 200-455 Cross Vetpharm Group Ltd. Tylosin Veterinary Oversight
(79 FR 64114, October 28, 2014)
Generic 200-460 Cross Vetpharm Group Ltd. Oxytetracycline Supplemental application approved to change to veterinary oversight*
Generic 200-473 Huvepharma EOOD Tylosin Veterinary Oversight
(79 FR 44277, July 31, 2014)
Generic 200-484 Huvepharma EOOD Tylosin Supplemental application approved to remove production indication and change to veterinary oversight*
Generic 200-494 Cross Vetpharm Group Ltd. Gentamicin Supplemental application approved to change to veterinary oversight*
Generic 200-510 Pharmgate LLC Chlortetracycline Supplemental application approved to remove production indication and change to veterinary oversight*
Generic 200-531 Huvepharma EOOD Monensin, Tylosin Supplemental application approved to change to veterinary oversight*
Generic 200-532 Huvepharma EOOD Melengestrol, Tylosin Supplemental application approved to change to veterinary oversight*
Generic 200-533 Huvepharma EOOD Monensin, Decoquinate, Tylosin Supplemental application approved to change to veterinary oversight*
Generic 200-534 Huvepharma EOOD Melengestrol, Tylosin, Monensin Supplemental application approved to change to veterinary oversight*
Generic 200-535 Huvepharma EOOD Lasalocid, Melengestrol, Tylosin Supplemental application approved to change to veterinary oversight*
Generic 200-544 Huvepharma EOOD Tylosin, Zilpaterol, Melengestrol, Monensin Supplemental application approved to change to veterinary oversight*
Generic 200-547 Huvepharma EOOD Monensin, Tylosin, Zilpaterol Supplemental application approved to change to veterinary oversight*
Combination 012-548 Elanco US, Inc. Hygromycin B, Tylosin Application Voluntarily Withdrawn
(81 FR 59131, August 29, 2016;
81 FR 59135, August 29, 2016)
Combination 013-388 Elanco US, Inc. Hygromycin B, Tylosin Application Voluntarily Withdrawn
(81 FR 59131, August 29, 2016;
81 FR 59135, August 29, 2016)
Combination 036-361 Zoetis Inc. Amprolium, Sodium Sulfate, Chlortetracycline , Ethopabate Supplemental application approved to change to veterinary oversight*
Combination 044-820 Zoetis Inc. Lincomycin, Amprolium, Ethopabate Sponsor has requested withdrawal of approval*
Combination 044-972 Zoetis Inc. Lincomycin, Clopidol Sponsor has requested withdrawal of approval*
Combination 045-444 Zoetis Inc. Chlortetracycline, Decoquinate Supplemental application approved to change to veterinary oversight*
Combination 046-209 Huvepharma EOOD Chlortetracycline, Clopidol Supplemental application approved to change to veterinary oversight*
Combination 046-718 Zoetis Inc. Melengestrol, Oxytetracycline Supplemental application approved to remove production indication and change to veterinary oversight*
Combination 046-719 Zoetis Inc Melengestrol, Oxytetracycline Supplemental application approved to remove production indication and change to veterinary oversight*
Combination 047-261 Zoetis Inc. Lincomycin, Decoquinate Sponsor has requested withdrawal of approval*
Combination 047-262 Zoetis Inc. Lincomycin, Decoquinate Sponsor has requested withdrawal of approval*
Combination 048-954 Zoetis Inc. Lincomycin, Zoalene Sponsor has requested withdrawal of approval*
Combination 092-482 Zoetis Inc. Lincomycin, Monensin Sponsor has requested withdrawal of approval*
Combination 092-507 Zoetis Inc. Robenidine, Chlortetracycline Supplemental application approved to change to veterinary oversight*
Combination 092-522 Zoetis Inc. Lincomycin, Monensin, Roxarsone Application Voluntarily Withdrawn
(79 FR 10974, February 27, 2014;
79 FR 10976, February 27, 2014)
Combination 093-106 Zoetis Inc. Robenidine, Lincomycin Sponsor has requested withdrawal of approval*
Combination 099-006 Phibro Animal Health Corp. Monensin, Oxytetracycline Supplemental application approved to change to veterinary oversight*
Combination 101-666 Phibro Animal Health Corp. Robenidine, Oxytetracycline Supplemental application approved to change to veterinary oversight*
Combination 101-689 Zoetis Inc. Lasalocid, Lincomycin Sponsor has requested withdrawal of approval*
Combination 104-646 Elanco US, Inc. Monensin, Tylosin Supplemental application approved to change to veterinary oversight*
Combination 107-997 Phibro Animal Health Corp. Lincomycin, Roxarsone, Nicarbazin Application Voluntarily Withdrawn
(79 FR 10974, February 27, 2014;
79 FR 10976, February 27, 2014)
Combination 108-116 Phibro Animal Health Corp. Lincomycin, Nicarbazin Sponsor has requested withdrawal of approval*
Combination 110-047 Phibro Animal Health Corp. Pyrantel, Tylosin Supplemental application approved to change to veterinary oversight*
Combination 116-044 Phibro Animal Health Corp. Pyrantel, Lincomycin Supplemental application approved to change to veterinary oversight*
Combination 120-724 Phibro Animal Health Corp. Monensin, Roxarsone, Virginiamycin Application Voluntarily Withdrawn
(79 FR 10974, February 27, 2014;
79 FR 10976, February 27, 2014)
Combination 121-553 Zoetis Inc. Monensin, Chlortetracycline Supplemental application approved to change to veterinary oversight*
Combination 122-481 Phibro Animal Health Corp. Monensin, Virginiamycin Sponsor has requested withdrawal of approval*
Combination 122-608 Phibro Animal Health Corp. Lasalocid, Virginiamycin Sponsor has requested withdrawal of approval*
Combination 122-822 Phibro Animal Health Corp. Amprolium, Virginiamycin, Ethopabate Sponsor has requested withdrawal of approval*
Combination 137-537 Zoetis Inc. Lincomycin, Salinomycin Sponsor has requested withdrawal of approval* 
Combination 138-792 Zoetis Inc. Melengestrol, Monensin, Tylosin Sponsor has requested withdrawal of approval* 
Combination 138-828 Phibro Animal Health Corp. Salinomycin, Virginiamycin Sponsor has requested withdrawal of approval* 
Combination 138-870 Zoetis Inc. Melengestrol, Monensin, Tylosin Supplemental application approved to change to veterinary oversight*
Combination 138-904 Zoetis Inc. Lasalocid, Melengestrol, Tylosin Sponsor has requested withdrawal of approval* 
Combination 138-941 Zoetis Inc. Pyrantel, Lincomycin Supplemental application approved to change to veterinary oversight*
Combination 138-953 Phibro Animal Health Corp. Roxarsone, Salinomycin, Virginiamycin Application Voluntarily Withdrawn
(79 FR 10974, February 27, 2014;
79 FR 10976, February 27, 2014)
Combination 138-992 Zoetis Inc. Lasalocid, Melengestrol, Tylosin Supplemental application approved to change to veterinary oversight*
Combination 138-995 Zoetis Inc. Melengestrol, Tylosin Supplemental application approved to change to veterinary oversight*
Combination 139-192 Zoetis Inc. Melengestrol, Tylosin Supplemental application approved to change to veterinary oversight*
Combination 139-473 Huvepharma EOOD Halofuginone, Virginiamycin Sponsor has requested withdrawal of approval*
Combination 140-340 Huvepharma EOOD Halofuginone, Lincomycin Sponsor has requested withdrawal of approval*
Combination 140-448 Phibro Animal Health Corp. Salinomycin, Oxytetracycline Supplemental application approved to change to veterinary oversight*
Combination 140-579 Zoetis Inc. Lasalocid, Oxytetracycline Supplemental application approved to change to veterinary oversight*
Combination 140-859 Zoetis Inc. Salinomycin, Chlortetracycline Supplemental application approved to change to veterinary oversight*
Combination 140-947 Elanco US, Inc. Lincomycin, Narasin, Nicarbazin Sponsor has requested withdrawal of approval*
Combination 140-954 Intervet, Inc. Lincomycin, Fenbendazole Supplemental application approved to remove production indication and change to veterinary oversight*
Combination 141-011 Elanco US, Inc. Chlortetracycline, Tiamulin Supplemental application approved to change to veterinary oversight*
Combination 141-054 Merial Ltd. Ivermectin, Lincomycin Supplemental application approved to remove production indication and change to veterinary oversight*
Combination 141-059 Zoetis Inc. Bacitracin, Chlortetracycline Supplemental application approved to change to veterinary oversight*
Combination 141-090 Huvepharma EOOD Diclazuril, Virginiamycin Sponsor has requested withdrawal of approval*
Combination 141-110 Phibro Animal Health Corp. Monensin, Virginiamycin Sponsor has requested withdrawal of approval*
Combination 141-114  Phibro Animal Health Corp. Semduramicin, Virginiamycin Supplemental application approved to remove production indication and change to veterinary oversight*
Combination 141-147 Zoetis Inc. Chlortetracycline, Decoquinate Supplemental application approved to change to veterinary oversight*
Combination 141-149 Zoetis Inc. Monensin, Decoquinate, Tylosin Supplemental application approved to change to veterinary oversight*
Combination 141-150 Zoetis Inc. Lasalocid, Virginiamycin Sponsor has requested withdrawal of approval*
Combination 141-164 Elanco US, Inc. Monensin, Tylosin Application Voluntarily Withdrawn
(81 FR 59131, August 29, 2016;
81 FR 59135, August 29, 2016)
Combination 141-170 Elanco US, Inc. Narasin, Tylosin Application Voluntarily Withdrawn
(81 FR 59131, August 29, 2016;
81 FR 59135, August 29, 2016)
Combination 141-172 Elanco US, Inc. Ractopamine, Tylosin Supplemental application approved to change to veterinary oversight*
Combination 141-185 Zoetis Inc. Chlortetracycline, Decoquinate Supplemental application approved to change to veterinary oversight*
Combination 141-198 Elanco US, Inc. Salinomycin, Tylosin Application Voluntarily Withdrawn
(81 FR 59131, August 29, 2016;
81 FR 59135, August 29, 2016)
Combination 141-201 Zoetis Inc. Laidlomycin, Chlortetracycline Supplemental application approved to change to veterinary oversight*
Combination 141-211 Phibro Animal Health Corp. Oxytetracycline, Carbadox Supplemental application approved to change to veterinary oversight*
Combination 141-224 Elanco US, Inc. Monensin, Ractopamine, Tylosin Supplemental application approved to change to veterinary oversight*
Combination 141-226 Phibro Animal Health Corp. Semduramicin, Roxarsone, Virginiamycin Application Voluntarily Withdrawn
(79 FR 10974, February 27, 2014;
79 FR 10976, February 27, 2014)
Combination 141-233 Elanco US, Inc. Monensin, Ractopamine, Melengestrol, Tylosin Supplemental application approved to change to veterinary oversight*
Combination 141-250 Zoetis Inc. Lasalocid, Chlortetracycline Supplemental application approved to change to veterinary oversight*
Combination 141-276 Intervet, Inc. Zilpaterol, Monensin, Tylosin Supplemental application approved to change to veterinary oversight*
Combination 141-280 Intervet, Inc. Zilpaterol, Melengestrol, Monensin, Tylosin Supplemental application approved to change to veterinary oversight*
Combination 141-289 Phibro Animal Health Corp. Semduramicin, Virginiamycin Supplemental application approved to remove production indication and change to veterinary oversight*
Combination 141-430 Phibro Animal Health Corp. Virginiamycin, Monensin Supplemental application approved to change to veterinary oversight*
Combination 200-090 Huvepharma EOOD Salinomycin, Lincomycin, Roxarsone Application Voluntarily Withdrawn
(79 FR 10974, February 27, 2014;
79 FR 10976, February 27, 2014)
Combination 200-091 Huvepharma EOOD Salinomycin, Roxarsone, Chlortetracycline Application Voluntarily Withdrawn
(79 FR 10974, February 27, 2014;
79 FR 10976, February 27, 2014)
Combination 200-092 Huvepharma EOOD Salinomycin, Virginiamycin Sponsor has requested withdrawal of approval*
Combination 200-093 Huvepharma EOOD Salinomycin, Lincomycin Sponsor has requested withdrawal of approval*
Combination 200-094 Huvepharma EOOD Salinomycin, Roxarsone, Virginiamycin Application Voluntarily Withdrawn
(79 FR 10974, February 27, 2014;
79 FR 10976, February 27, 2014)
Combination 200-095 Huvepharma EOOD Salinomycin, Chlortetracycline Supplemental application approved to change to veterinary oversight*
Combination 200-096 Huvepharma EOOD Salinomycin, Oxytetracycline Supplemental application approved to change to veterinary oversight*
Combination 200-170 Phibro Animal Health Corp. Lincomycin, Roxarsone, Nicarbazin Application Voluntarily Withdrawn
(79 FR 10974, February 27, 2014;
79 FR 10976, February 27, 2014)
Combination 200-171 Phibro Animal Health Corp. Lincomycin, Nicarbazin Sponsor has requested withdrawal of approval*
Combination 200-242 Zoetis Inc. Bacitracin, Chlortetracycline Supplemental application approved to change to veterinary oversight*
Combination 200-259 Zoetis Inc. Salinomycin, Roxarsone, Chlortetracycline Application Voluntarily Withdrawn
(79 FR 10974, February 27, 2014;
79 FR 10976, February 27, 2014)
Combination 200-260 Zoetis Inc. Salinomycin, Roxarsone, Chlortetracycline Application Voluntarily Withdrawn
(79 FR 10974, February 27, 2014;
79 FR 10976, February 27, 2014)
Combination 200-261 Zoetis Inc. Salinomycin, Chlortetracycline Supplemental application approved to change to veterinary oversight*
Combination 200-262 Zoetis Inc. Salinomycin, Chlortetracycline Supplemental application approved to change to veterinary oversight*
Combination 200-263 Zoetis Inc. Monensin, Chlortetracycline Supplemental application approved to change to veterinary oversight*
Combination 200-354 Pharmgate LLC Monensin, Chlortetracycline Supplemental application approved to change to veterinary oversight*
Combination 200-355 Pennfield Oil Co. Salinomycin, Roxarsone, Chlortetracycline Application Voluntarily Withdrawn
(79 FR 10974, February 27, 2014;
79 FR 10976, February 27, 2014)
Combination 200-356 Pharmgate LLC Chlortetracycline, Tiamulin Supplemental application approved to change to veterinary oversight*
Combination 200-357 Pharmgate LLC Salinomycin, Chlortetracycline Supplemental application approved to change to veterinary oversight*
Combination 200-358 Pharmgate LLC Bacitracin, Chlortetracycline Supplemental application approved to change to veterinary oversight*
Combination 200-359 Pharmgate LLC Chlortetracycline, Decoquinate Supplemental application approved to change to veterinary oversight*
Combination 200-375 Elanco US, Inc. Melengestrol, Monensin, Tylosin Supplemental application approved to change to veterinary oversight*
Combination 200-424 Elanco US, Inc. Monensin, Ractopamine, Melengestrol, Tylosin Supplemental application approved to change to veterinary oversight*
Combination 200-427 Elanco US, Inc. Melengestrol, Tylosin Supplemental application approved to change to veterinary oversight*
Combination 200-430 Elanco US, Inc. Lasalocid, Melengestrol, Tylosin Supplemental application approved to change to veterinary oversight*
Combination 200-480 Elanco US, Inc. Melengestrol, Tylosin, Monensin, Zilpaterol Supplemental application approved to change to veterinary oversight*
Combination 200-530 Huvepharma EOOD Tylosin, Ractopamine Supplemental application approved to change to veterinary oversight*
Combination 200-558 Zoetis Inc. Tylosin, Ractopamine Supplemental application approved to change to veterinary oversight*
Combination 200-561 Zoetis Inc. Tylosin, Monensin, Ractopamine Supplemental application approved to change to veterinary oversight*
Combination 200-562 Zoetis Inc. Tylosin, Monensin, Ractopamine, MGA Supplemental application approved to change to veterinary oversight*
Combination 200-566 Huvepharma EOOD Tylosin, Monensin, Ractopamine Supplemental application approved to change to veterinary oversight*
Combination 200-567 Huvepharma EOOD Tylosin, Monensin, Ractopamine, MGA Supplemental application approved to change to veterinary oversight*
Combination 200-569 Huvepharma EOOD Tylosin, Salinomycin Sponsor has requested withdrawal of approval*
Combination 200-570 Huvepharma EOOD Tylosin, Salinomycin Sponsor has requested withdrawal of approval*
Combination 200-580 Huvepharma EOOD Tylosin, Salinomycin Sponsor has requested withdrawal of approval*
Combination 200-583 Zoetis Inc. Ractopamine, Monensin, Tylosin, MGA Supplemental application approved to change to veterinary oversight*
Combination 200-584 Zoetis Inc. Ractopamine, Tylosin Supplemental application approved to change to veterinary oversight*
Combination 200-585 Zoetis Inc. Ractopamine, Monensin, Tylosin Supplemental application approved to change to veterinary oversight*

 *FR Notice Pending

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