Implantation or Injectable Dosage Form New Animal Drugs; Sometribove Zinc Suspension
fda-drug · Food and Drug Administration · Rule · Published 2003-10-31 · Effective 2003-10-31 · 68 FR 62005
Document
Document number
03-27395
Federal Register citation
68 FR 62005
CFR reference
21 CFR 510
Type
Rule
Action
Final rule; technical amendment.
Category
fda-drug
Sub-agency
Food and Drug Administration
Publication date
2003-10-31
Effective date
2003-10-31
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 Monsanto Co. The supplemental NADA provides for revised wording of the indication and precautionary labeling for sometribove zinc suspension used to increase the production of marketable milk in healthy lactating dairy cows. The regulations are also being amended to reflect a different drug labeler code (DLC) for Monsanto Co.