# Antibiotic Drugs; Clarithromycin Granules for Oral Suspension
> **Food and Drug Administration** · Final rule. · Published 1996-07-03 · Effective 1996-08-02 · 61 FR 34726
## Document
- **Document number:** 96-16977
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 61 FR 34726
- **CFR reference:** 21 CFR 452
- **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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/1996/07/03/96-16977/antibiotic-drugs-clarithromycin-granules-for-oral-suspension)
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