other · US Department of Health and Human Services · Rule · Published 1995-09-26 · Effective 1995-10-26 · 60 FR 49507
Document
Document number
95-23737
Federal Register citation
60 FR 49507
CFR reference
21 CFR 453
Type
Rule
Action
Final rule.
Category
other
Sub-agency
US Department of Health and Human Services
Publication date
1995-09-26
Effective date
1995-10-26
HHS docket
Docket No. 95N-0081
Abstract
The Food and Drug Administration (FDA) is amending the antibiotic drug regulations to include accepted standards for a new antibiotic drug, clindamycin phosphate vaginal cream. The manufacturer has supplied sufficient data and information to establish its safety and efficacy.