Antibiotic Drugs; Clarithromycin Granules for Oral Suspension
other · Food and Drug Administration · Rule · Published 1996-07-03 · Effective 1996-08-02 · 61 FR 34726
Document
Document number
96-16977
Federal Register citation
61 FR 34726
CFR reference
21 CFR 452
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1996-07-03
Effective date
1996-08-02
HHS docket
Docket No. 96N-0117
Abstract
The Food and Drug Administration (FDA) is amending the antibiotic drug regulations to include accepted standards for clarithromycin for its use in a new dosage form of clarithromycin, clarithromycin granules for oral suspension. The manufacturer has supplied sufficient data and information to establish its safety and efficacy.