Implantation or Injectable Dosage Form New Animal Drugs; Chorionic Gonadotropin
other · Food and Drug Administration · Rule · Published 1999-09-07 · Effective 1999-09-07 · 64 FR 48544
Document
Document number
99-23132
Federal Register citation
64 FR 48544
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1999-09-07
Effective date
1999-09-07
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 Intervet, Inc. The supplemental NADA provides for intramuscular use of chorionic gonadotropin, a freeze- dried powder reconstituted for intramuscular injection in male and female brood finfish as an aid in improving spawning function. The regulations are also amended to establish an acceptable daily intake (ADI) for total gonadotropins.