This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.
This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office] .
It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.
United States Code U.S. Code: Title 21 - FOOD AND DRUGS
Title 21 published on 09-Jun-2018 03:51
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 510 after this date.
2018-04-05; vol. 83 # 66 - Thursday, April 5, 2018 83 FR 14584 - New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name and Address
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective April 5, 2018. 21 CFR Parts 510, 520, 522, 526, and 558 Summary The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during October, November, and December 2017. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of applications and a change of a sponsor's name and address.
2018-03-30; vol. 83 # 62 - Friday, March 30, 2018 83 FR 13632 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name and Address
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendments. This rule is effective March 30, 2018, except for amendatory instructions 3 to 21 CFR 510.600, 9 to 21 CFR 522.300, 10 to 21 CFR 522.540, and 11 to 21 CFR 522.1081, which are effective April 9, 2018. 21 CFR Parts 510, 520, 522, 524, 556, and 558 Summary The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July, August, and September 2017. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect the withdrawal of approval of applications, changes of sponsorship of applications, and a change of a sponsor's name and address, and to make technical amendments to improve the accuracy of the regulations.
2017-12-13; vol. 82 # 238 - Wednesday, December 13, 2017 82 FR 58554 - New Animal Drugs; Approval of New Animal Drug Applications
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendments. This rule is effective December 13, 2017. 21 CFR Parts 510, 520, 522, 524, 529, and 558 Summary The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for a new animal drug application (NADA) and abbreviated new animal drug applications (ANADAs) during May and June 2017. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to make technical amendments to improve the accuracy of the regulations.
2017-09-18; vol. 82 # 179 - Monday, September 18, 2017 82 FR 43482 - New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor's Address
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendments. This rule is effective September 18, 2017. 21 CFR Parts 510, 520, 522, 524, and 558 Summary The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for a new animal drug application (NADA) and abbreviated new animal drug applications (ANADAs) during March and April 2017. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of a sponsor's address and to make technical amendments to improve the accuracy of the regulations.
2017-05-10; vol. 82 # 89 - Wednesday, May 10, 2017 82 FR 21688 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; correcting amendments. This rule is effective May 10, 2017, except for amendatory instruction 3 to 21 CFR 510.600, and amendatory instruction 10 to 21 CFR 522.1002, which are effective May 22, 2017. 21 CFR Parts 510, 520, 522, 524, and 558 Summary The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January and February 2017. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect several changes of sponsorship of applications and to make correcting amendments to improve the accuracy of the regulations.
2017-03-01; vol. 82 # 39 - Wednesday, March 1, 2017 82 FR 12167 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor; Change of Sponsor's Name
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 1, 2017, except for amendments 2.a and 2.c to 21 CFR 510.600, and the amendments to 21 CFR 522.313c and 529.1186, which are effective March 13, 2017. 21 CFR Parts 510, 516, 520, 522, 529, and 558 Summary The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during November and December 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect the change of sponsorship of an application and a change of a sponsor's name.
82 FR 12170 - New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification of withdrawal. Withdrawal of approval is effective March 13, 2017. 21 CFR Parts 510, 522, and 529 Summary The Food and Drug Administration (FDA) is withdrawing approval of a new animal drug application (NADA) and an abbreviated new animal drug application (ANADA) at the sponsors' requests because the products are no longer manufactured or marketed.
2017-02-24; vol. 82 # 36 - Friday, February 24, 2017 82 FR 11506 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor; Change of Sponsor's Address
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendment. This rule is effective February 24, 2017, except for the amendment to 21 CFR 524.1465, which is effective March 6, 2017. 21 CFR Parts 510, 520, 522, 524, and 558 Summary The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during September and October 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of several applications and a change of a sponsor's address.
2016-09-30; vol. 81 # 190 - Friday, September 30, 2016 81 FR 67149 - New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor's Address
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendment. This rule is effective September 30, 2016. 21 CFR Parts 510, 520, 522, 524, 529, and 558 Summary The Food and Drug Administration (FDA, we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July and August 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of a sponsor's address.
2016-08-29; vol. 81 # 167 - Monday, August 29, 2016 81 FR 59131 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of Sponsor's Name and Address; Change of Sponsor's Address
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendment. This rule is effective August 29, 2016, except for the amendments to 21 CFR 558.274, 58.355, 58.363, 58.550, 558.625, and 558.630, which are effective September 8, 2016. 21 CFR Parts 510, 520, 522, 524, and 558 Summary The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during May and June 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of applications, changes of sponsors' names and addresses, and the voluntary withdrawals of approval of applications.
2016-07-26; vol. 81 # 143 - Tuesday, July 26, 2016 81 FR 48700 - 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 July 26, 2016. 21 CFR Parts 510, 520, 522, 524, and 558 Summary The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 57 approved new animal drug applications (NADAs) and 14 approved abbreviated new animal drug applications (ANADAs) from Elanco Animal Health, A Division of Eli Lilly & Co. to Elanco US, Inc.
2016-06-08; vol. 81 # 110 - Wednesday, June 8, 2016 81 FR 36787 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendment. This rule is effective June 8, 2016 except for the amendments to 21 CFR 520.1696b, 520.2325a, 520.2261a, 558.248, and 558.625, which are effective June 20, 2016. 21 CFR Parts 510, 520, 522, 556, and 558 Summary The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during March and April 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of applications and the voluntary withdrawals of approval of applications that occurred in January and February.
2016-04-01; vol. 81 # 63 - Friday, April 1, 2016 81 FR - New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration 21 CFR Parts 510, 520, 522, 524, 528, 529, 556, and 558 Summary
2016-03-30; vol. 81 # 61 - Wednesday, March 30, 2016 81 FR 17604 - New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship
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 30, 2016. 21 CFR Parts 510, 520, 522, 524, 528, 529, 556, and 558 Summary The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during November and December 2015. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of applications that occurred in November and December 2015.
2016-01-21; vol. 81 # 13 - Thursday, January 21, 2016 81 FR 3324 - Conditional Approval of a New Animal Drug No Longer in Effect; Masitinib
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective January 21, 2016. 21 CFR Parts 510 and 516 Summary The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect that the conditional approval of an application for masitinib mesylate tablets, a new animal drug for a minor use, is no longer in effect.
2015-12-09; vol. 80 # 236 - Wednesday, December 9, 2015 80 FR 76384 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawals of Approval of New Animal Drug Applications; Changes of Sponsorship
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendments. This rule is effective December 9, 2015, except for the amendments to 21 CFR 520.446, 520.2043, 558.625, and 558.630, which are effective December 21, 2015. 21 CFR Parts 510, 520, 522, 524, and 558 Summary The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during September and October 2015. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of applications and the voluntary withdrawals of approval of applications that occurred in September and October 2015.
2015-11-24; vol. 80 # 226 - Tuesday, November 24, 2015 80 FR 73104 - New Animal Drugs in Genetically Engineered Animals; opAFP-GHc2 Recombinant Deoxyribonucleic Acid Construct
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective November 24, 2015. 21 CFR Parts 510 and 528 Summary The Food and Drug Administration (FDA, the Agency) is amending the animal drug regulations to reflect the approval of a new animal drug application (NADA) filed by AquaBounty Technologies, Inc. The NADA provides for use of a recombinant deoxyribonucleic acid (rDNA) gene construct in a lineage of genetically engineered Atlantic salmon.
2015-10-13; vol. 80 # 197 - Tuesday, October 13, 2015 80 FR 61293 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor; Change of Sponsor's Address
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendment. This rule is effective October 13, 2015, except for the amendment to 21 CFR 558.460, which is effective October 23, 2015. 21 CFR Parts 510, 520, 522, 524, 556, and 558 Summary The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July and August 2015. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsor, a change of sponsor's address, a revised food safety warning, the voluntary withdrawal of approval of an NADA, and a technical amendment. This technical amendment is being made to improve the accuracy of the regulations.
2015-06-16; vol. 80 # 115 - Tuesday, June 16, 2015 80 FR 34276 - New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendments. This rule is effective June 16, 2015. 21 CFR Parts 510, 520, 522, 526, and 528 Summary The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during March and April 2015. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect several nonsubstantive changes. These technical amendments are being made to improve the accuracy of the regulations.
2015-04-08; vol. 80 # 67 - Wednesday, April 8, 2015 80 FR 18773 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor's Name; Change of Sponsor's Address
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendments. This rule is effective April 8, 2015, except for the amendment to 21 CFR 522.1004, which is effective April 20, 2015. 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 application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January and February 2015. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect several non-substantive changes. These technical amendments are being made to improve the accuracy of the regulations.
2014-12-15; vol. 79 # 240 - Monday, December 15, 2014 79 FR 74018 - New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor; Withdrawal of Approval of New Animal Drug Applications
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule, technical amendment. This rule is effective December 15, 2014, except for the amendment to 21 CFR 520.1660d, which is effective December 26, 2014. 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 September and October 2014. FDA is also informing the public of the availability of summaries of 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 of six NADAs and four ANADAs, the voluntary withdrawal of approval of an ANADA, and a correcting amendment.
2014-10-28; vol. 79 # 208 - Tuesday, October 28, 2014 79 FR 64114 - New Animal Drugs; Alfaxalone; Dinoprost; Ivermectin and Clorsulon; Nitrofurazone; Trenbolone and Estradiol Benzoate; Trimethoprim and Sulfadiazine; Tylosin; Change of Sponsor
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule, technical amendment. This rule is effective October 28, 2014. 21 CFR Parts 510, 520, 522, 524, and 556 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 August 2014. FDA is also informing the public of the availability of summaries of 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 of two NADAs and one ANADA, and to reflect a revised food safety warning.
2014-07-02; vol. 79 # 127 - Wednesday, July 2, 2014 79 FR 37617 - New Animal Drugs; Afoxalaner; Ceftiofur Crystalline Free Acid; Chloramine-T; Clodronate; Enrofloxacin; Eprinomectin; Fluralaner; Ivermectin and Praziquantel; Niclosamide; Ractopamine; Tylosin; Change of Sponsor's Address
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendment. This rule is effective July 2, 2014. 21 CFR Parts 510, 520, 522, 529, 556, 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 and May 2014. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to remove an obsolete entry for a drug for which approval was withdrawn in 1996.
2014-05-20; vol. 79 # 97 - Tuesday, May 20, 2014 79 FR 28813 - Oral Dosage Form New Animal Drugs; Change of Sponsor
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendments. This rule is effective May 20, 2014. 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 172 approved new animal drug applications (NADAs) and 14 approved abbreviated new animal drug applications (ANADAs) for oral dosage form new animal drug products from Pfizer, Inc., including its several subsidiaries and divisions, to Zoetis, Inc. FDA is also amending the animal drug regulations to remove entries describing conditions of use for new animal drug products for which no NADA is approved, to make minor corrections, and to reflect a current format. This is being done to increase the accuracy and readability of the regulations.
2014-04-10; vol. 79 # 69 - Thursday, April 10, 2014 79 FR 19814 - Withdrawal of Approval of New Animal Drug Applications; Bambermycins; Hygromycin B; Lincomycin; Pyrantel; Tylosin; Tylosin and Sulfamethazine; Virginiamycin
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification of withdrawal. Withdrawal of approval is effective April 21, 2014. 21 CFR Parts 510 and 558 Summary The Food and Drug Administration (FDA) is withdrawing approval of 19 new animal drug applications (NADAs) for certain Type A medicated articles and Type B medicated feeds. This action is being taken at the sponsors' request because these products are no longer manufactured or marketed.
79 FR 19814 - New Animal Drugs for Use in Animal Feeds; Withdrawal of Approval of New Animal Drug Applications; Bambermycins; Hygromycin B; Lincomycin; Pyrantel; Tylosin; Tylosin and Sulfamethazine; Virginiamycin
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendment. This final rule is effective April 21, 2014. 21 CFR Parts 510 and 558 Summary The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of 19 new animal drug applications (NADAs) for certain Type A medicated articles and Type B medicated feeds. This action is being taken at the sponsors' request because these products are no longer manufactured or marketed.
2014-04-01; vol. 79 # 62 - Tuesday, April 1, 2014 79 FR 18156 - New Animal Drugs; Amprolium; Bambermycins; Ceftiofur; Deslorelin; Florfenicol; Florfenicol and Flunixin; Paclitaxel; Phenylbutazone; Pimobendan; Salinomycin; Tilmicosin; Tiludronate; 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 1, 2014. 21 CFR Parts 510, 516, 520, 522, 526, 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 January and February 2014. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect previous approval of revised food safety warnings. This is being done to improve the accuracy of the regulations. The animal drug regulations are also being amended to reflect a change of sponsorship of an NADA and a change to a sponsor's address.
2014-02-27; vol. 79 # 39 - Thursday, February 27, 2014 79 FR 10963 - New Animal Drugs; Bambermycins; Clopidol; Ivermectin; Penicillin G Procaine and Dihydrostreptomycin Sulfate; Progesterone; Robenicoxib; Sulfadimethoxine; Change of Sponsor; Change of Sponsor's Address
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective February 27, 2014. 21 CFR Parts 510, 520, 522, 526, 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 December 2013. FDA is also informing the public of the availability of summaries of 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 of an NADA and a change to a sponsor's address.
2014-01-16; vol. 79 # 11 - Thursday, January 16, 2014 79 FR 2785 - Withdrawal of Approval of New Animal Drug Applications; Argent Laboratories; Formalin; Tricaine Methanesulfonate
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This final rule is effective January 27, 2014. 21 CFR Parts 510 and 529 Summary The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of two new animal drug applications (NADAs) held by Argent Laboratories. Withdrawal of approval of these NADAs was at the sponsor's request because the products are no longer manufactured or marketed.
79 FR 2785 - Withdrawal of Approval of New Animal Drug Applications; Argent Laboratories; Formalin; Tricaine Methanesulfonate
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification of withdrawal. Withdrawal of approval is effective January 27, 2014. 21 CFR Parts 510 and 529 Summary The Food and Drug Administration (FDA) is withdrawing approval of two new animal drug applications (NADAs) held by Argent Laboratories. Withdrawal of approval of these NADAs was at the sponsor's request because the products are no longer manufactured or marketed.
2013-12-09; vol. 78 # 236 - Monday, December 9, 2013 78 FR 73697 - New Animal Drugs; Hyaluronate Sodium; Hydrogen Peroxide; Imidacloprid and Moxidectin; 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 December 9, 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 October 2013. FDA is also informing the public of the availability of summaries of 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 of an ANADA.
2013-11-05; vol. 78 # 214 - Tuesday, November 5, 2013 78 FR 66263 - New Animal Drugs; Afoxolaner; Carprofen; Ceftiofur Hydrochloride; Monensin
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective November 5, 2013. 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 September 2013. FDA is also informing the public of the availability of summaries on 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 an ANADA.
2013-10-25; vol. 78 # 207 - Friday, October 25, 2013 78 FR 63870 - New Animal Drugs; Change of Sponsor; Gonadorelin; Ivermectin; Ractopamine; Trimethoprim and Sulfadiazine Suspension; Tulathromycin
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective October 25, 2013. 21 CFR Parts 510, 520, 522, 524, 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 July 2013. FDA is also informing the public of the availability of summaries of 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 an ANADA.
2013-08-27; vol. 78 # 166 - Tuesday, August 27, 2013 78 FR 52852 - New Animal Drugs; Carprofen; Enrofloxacin; Florfenicol; Tildipirosin; Zilpaterol
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendment. This rule is effective August 27, 2013. 21 CFR Parts 510, 520, 524, 556, 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 June 2013. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
2013-08-23; vol. 78 # 164 - Friday, August 23, 2013 78 FR 52429 - New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications; Diethylcarbamazine; Nicarbazin; Penicillin
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective September 3, 2013. 21 CFR Parts 510, 520, and 558 Summary The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of three new animal drug applications (NADAs) at the sponsors' request because the products are no longer manufactured or marketed.
78 FR 52430 - Withdrawal of Approval of New Animal Drug Applications; Quali-Tech Products, Inc.; Bambermycins; Pyrantel; Tylosin; Virginiamycin
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. The rule is effective September 3, 2013. 21 CFR Parts 510 and 558 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), held by Quali-Tech Products, Inc., at the sponsor's request because the products are no longer manufactured or marketed.
2013-07-24; vol. 78 # 142 - Wednesday, July 24, 2013 78 FR 44432 - New Animal Drugs; Change of Sponsor; Fentanyl; Iron Injection
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective July 24, 2013. 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 approved new animal drug applications (NADAs) from Alstoe, Ltd., Animal Health, to Sogeval S.A., and a change of sponsor for an NADA from Nexcyon Pharmaceuticals, Inc. to Elanco Animal Health, A Division of Eli Lilly & Co.
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.
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