Implantation or Injectable Dosage Form New Animal Drugs; Change of Sponsor
other · Food and Drug Administration · Rule · Published 2014-03-25 · Effective 2014-03-25 · 79 FR 16180
Document
Document number
2014-06131
Federal Register citation
79 FR 16180
CFR reference
21 CFR 522
Type
Rule
Action
Final rule; technical amendment.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2014-03-25
Effective date
2014-03-25
HHS docket
Docket No. FDA-2014-N-0002
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 104 approved new animal drug applications (NADAs) and 5 approved abbreviated new animal drug applications (ANADAs) for implantation or injectable 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.