Implantation or Injectable Dosage Form New Animal Drugs; Gonadorelin Diacetate Tetrahydrate Injection
other · US Department of Health and Human Services · Rule · Published 1996-07-19 · 61 FR 37682
Document
Document number
96-18350
Federal Register citation
61 FR 37682
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
US Department of Health and Human Services
Publication date
1996-07-19
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Intervet, Inc. The ANADA provides for intramuscular and intravenous use of a sterile injectable solution of gonadorelin diacetate tetrahydrate for treating ovarian cysts in female dairy cattle of breeding age.