Antibiotic Drugs; Cefpodoxime Proxetil, Cefpodoxime Proxetil Tablets, and Cefpodoxime Proxetil Granules for Oral Suspension
other · Food and Drug Administration · Rule · Published 1995-11-27 · Effective 1995-12-27 · 60 FR 58229
Document
Document number
95-28893
Federal Register citation
60 FR 58229
CFR reference
21 CFR 430
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1995-11-27
Effective date
1995-12-27
HHS docket
Docket No. 95N-0186
Abstract
The Food and Drug Administration (FDA) is amending the antibiotic drug regulations to include accepted standards for a new antibiotic drug, cefpodoxime proxetil, and its use in two dosage forms, cefpodoxime proxetil tablets and cefpodoxime proxetil granules for oral suspension. The manufacturer has supplied sufficient data and information to establish its safety and efficacy.