Certain Other Dosage Form New Animal Drugs; Progesterone Intravaginal Inserts
other · Food and Drug Administration · Rule · Published 2010-10-14 · Effective 2010-10-14 · 75 FR 63085
Document
Document number
2010-25893
Federal Register citation
75 FR 63085
CFR reference
21 CFR 529
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2010-10-14
Effective date
2010-10-14
HHS docket
Docket No. FDA-2010-N-0002
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pharmacia & Upjohn Co., a Division of Pfizer, Inc. The supplemental NADA provides for use of progesterone intravaginal inserts and dinoprost tromethamine by injection for synchronization of estrus in lactating dairy cows.