Title 21 published on 2012-04-01
The following are only the Rules published in the Federal Register after the published date of Title 21.
For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.
2013-05-13; vol. 78 # 92 - Monday, May 13, 2013 78 FR 27859 - New Animal Drugs; Change of Sponsor's Name and Address; Change of Sponsor
GPO FDSys XML | Text Additional Documents
DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 13, 2013. 21 CFR Parts 510 and 558 Summary The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name and address from Purina Mills, Inc., to Purina Nutrition LLC, and a change of sponsor for a new animal drug application (NADA) from Land O'Lakes Purina Feed LLC to Purina Nutrition LLC. The regulations are also being amended to reflect that Zoetis Inc. is a sponsor of approved NADAs.
2013-04-09; vol. 78 # 68 - Tuesday, April 9, 2013 78 FR 21058 - New Animal Drugs; Change of Sponsor
GPO FDSys XML | Text Additional Documents
DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective April 9, 2013. 21 CFR Parts 510, 520, 522, 524, 526, 529, and 558 Summary The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 43 approved new animal drug applications (NADAs) and 3 approved abbreviated new animal drug applications (ANADAs) from Boehringer Ingelheim Vetmedica, Inc. to Strategic Veterinary Pharmaceuticals, Inc.
2013-04-03; vol. 78 # 64 - Wednesday, April 3, 2013 78 FR 19986 - New Animal Drugs; Enrofloxacin; Tilmicosin; Tylosin
GPO FDSys XML | Text Additional Documents
DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule, technical amendment. This rule is effective April 3, 2013. 21 CFR Parts 510, 522, and 558 Summary The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications and abbreviated new animal drug applications during February 2013. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable.
2013-03-25; vol. 78 # 57 - Monday, March 25, 2013 78 FR 17866 - New Animal Drug Approvals; Change of Sponsor; Change of Sponsor's Drug Labeler Code; Gonadorelin Acetate; Isoflurane; Praziquantel; Propofol; Sevoflurane; Triamcinolone Acetonide
GPO FDSys XML | Text Additional Documents
DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective March 25, 2013. 21 CFR Parts 510, 522, 524, and 529 Summary The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January 2013. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship for an NADA and ANADA, and a change of a sponsor's drug labeler code.
2013-03-22; vol. 78 # 56 - Friday, March 22, 2013 78 FR 17595 - New Animal Drugs; Changes of Sponsor
GPO FDSys XML | Text Additional Documents
DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective March 22, 2013. 21 CFR Parts 510, 520, 522, 524, 529, and 558 Summary The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 21 approved new animal drug applications (NADAs) and 43 approved abbreviated new animal drug applications (ANADAs) from Teva Animal Health, Inc., to Bayer HealthCare LLC.
2013-03-07; vol. 78 # 45 - Thursday, March 7, 2013 78 FR 14667 - New Animal Drug Applications; Alfaprostol; Bicyclohexylammonium Fumagillin; N -Butyl Chloride; Competitive Exclusion Culture; Dichlorophene and Toluene; Flurogestone Acetate; Isoflurane; Pyrantel; Tylosin; Tylosin and Sulfamethazine
GPO FDSys XML | Text Additional Documents
DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule, technical amendment. This rule is effective March 18, 2013. 21 CFR Parts 510, 520, 522, 529, and 558 Summary The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal approval of 19 new animal drug applications (NADAs) and one abbreviated new animal drug application (ANADA). The applications are being withdrawn for lack of compliance with the reporting requirements in an FDA regulation.
2013-01-28; vol. 78 # 18 - Monday, January 28, 2013 78 FR 5713 - New Animal Drugs; Cefpodoxime; Meloxicam
GPO FDSys XML | Text Additional Documents
DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendment. This rule is effective January 28, 2013. 21 CFR Parts 510, 520, and 522 Summary The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during December 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
2012-10-23; vol. 77 # 205 - Tuesday, October 23, 2012 77 FR 64715 - New Animal Drugs; Approvals; Changes of Sponsor; Change of Sponsor's Name; Change of Sponsor's Address; Alfaxalone; Ivermectin and Clorsulon; Narasin; Triptorelin
GPO FDSys XML | Text Additional Documents
DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective October 23, 2012. 21 CFR Parts 510, 522, 524, 529, and 558 Summary The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during September 2012. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship for four ophthalmic ointments, a change of sponsor's name, and a change of sponsor's address.
2012-10-04; vol. 77 # 193 - Thursday, October 4, 2012 77 FR 60622 - New Animal Drugs; Change of Sponsor's Address; Monensin; Spinosad; Tilmicosin
GPO FDSys XML | Text Additional Documents
DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective October 4, 2012. 21 CFR Parts 510, 520, and 558 Summary The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) during August 2012 and to reflect a change of sponsor's address for Baxter Healthcare Corp. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
2012-10-03; vol. 77 # 192 - Wednesday, October 3, 2012 77 FR 60301 - New Animal Drugs; Butorphanol; Doxapram; Triamcinolone; Tylosin
GPO FDSys XML | Text Additional Documents
DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective October 15, 2012. 21 CFR Parts 510, 522, 524, and 558 Summary The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal approval of a new animal drug application (NADA) and three abbreviated new animal drug applications (ANADAs) at the sponsors' request because the products are no longer manufactured or marketed.
2012-09-14; vol. 77 # 179 - Friday, September 14, 2012 77 FR 56769 - New Animal Drugs; Change of Sponsor; Change of Sponsor Address; Lincomycin and Spectinomycin Soluble Powder; Sulfadimethoxine Oral Solution and Soluble Powder; Tiamulin
GPO FDSys XML | Text Additional Documents
DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective September 14, 2012. 21 CFR Parts 510 and 520 Summary The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for three abbreviated new animal drug applications (ANADAs) from Teva Animal Health, Inc., to Phibro Animal Health Corp. FDA is also amending the regulations to reflect a change of sponsor's address for Phibro Animal Health Corp. and for Eka Chemicals, Inc.
2012-09-10; vol. 77 # 175 - Monday, September 10, 2012 77 FR 55413 - New Animal Drugs; Chorionic Gonadotropin; Naloxone; Oxymorphone; Oxytocin
GPO FDSys XML | Text Additional Documents
DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective September 20, 2012. 21 CFR Parts 510 and 522 Summary The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of four new animal drug applications (NADAs) at the sponsor's request because the products are no longer manufactured or marketed.
2012-08-09; vol. 77 # 154 - Thursday, August 9, 2012 77 FR 47511 - New Animal Drugs; Cephalexin; Fentanyl; Milbemycin Oxime and Praziquantel
GPO FDSys XML | Text Additional Documents
DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective August 9, 2012. 21 CFR Parts 510, 520, and 524 Summary The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during June 2012. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable.
2012-08-06; vol. 77 # 151 - Monday, August 6, 2012 77 FR 46612 - New Animal Drugs; Change of Sponsor; Change of Sponsor Address; Azaperone; Miconazole, Polymyxin B, and Prednisolone Suspension
GPO FDSys XML | Text Additional Documents
DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective August 6, 2012. 21 CFR Parts 510, 522, and 524 Summary The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for two new animal drug applications (NADAs) from Janssen Pharmaceutica NV, to Elanco Animal Health, a Division of Eli Lilly & Co. FDA is also amending the animal drug regulations to reflect a change of sponsor's address for Veterinary Service, Inc.
2012-06-04; vol. 77 # 107 - Monday, June 4, 2012 77 FR 32897 - New Animal Drugs; Change of Sponsor's Name
GPO FDSys XML | Text Additional Documents
DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective June 4, 2012. 21 CFR Part 510 Summary The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from Novopharm Ltd. to Teva Canada Ltd.
2012-05-31; vol. 77 # 105 - Thursday, May 31, 2012 77 FR 32010 - New Animal Drugs; Altrenogest; Dexamethasone; Florfenicol
GPO FDSys XML | Text Additional Documents
DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 31, 2012. 21 CFR Parts 510, 516, 520, 522, and 558 Summary The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during April 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
2012-05-30; vol. 77 # 104 - Wednesday, May 30, 2012 77 FR 31722 - New Animal Drugs; Change of Sponsor; Estradiol; Estradiol Benzoate and Testosterone Propionate; Progesterone and Estradiol Benzoate; Trenbolone Acetate; Trenbolone Acetate and Estradiol; Melengestrol; Ractopamine; Zilpaterol
GPO FDSys XML | Text Additional Documents
DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 30, 2012. 21 CFR Parts 510, 522, and 558 Summary The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 17 new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) for various steroid ear implants for cattle and for melengestrol acetate liquid Type A medicated article and use in combination medicated feeds for heifers fed in confinement for slaughter from Ivy Laboratories, Division of Ivy Animal Health, Inc., to Elanco Animal Health, Division of Eli Lilly & Co.
2012-05-17; vol. 77 # 96 - Thursday, May 17, 2012 77 FR 29216 - New Animal Drugs; Ceftiofur Sodium; Lincomycin Powder; Naracin; Tylosin
GPO FDSys XML | Text Additional Documents
DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 17, 2012. 21 CFR Parts 510, 520, 522, and 558 Summary The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during March 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
2012-05-07; vol. 77 # 88 - Monday, May 7, 2012 77 FR 26697 - New Animal Drugs; Change of Sponsor; Change of Sponsor Address; Change of Sponsor Name and Address; Fomepizole
GPO FDSys XML | Text Additional Documents
DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 7, 2012. 21 CFR Parts 510 and 522 Summary The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor name from Bioniche Teoranta to Mylan Institutional, LLC; a change of sponsor for fomepizole injectable solution from Synerx Pharma, LLC, to Mylan Institutional, LLC; and a change of sponsor address for Modern Veterinary Therapeutics, LLC.
