Antibiotic Drugs; Cefuroxime Axetil for Oral Suspension
other · Food and Drug Administration · Rule · Published 1995-05-23 · Effective 1995-06-22 · 60 FR 27221
Document
Document number
95-12604
Federal Register citation
60 FR 27221
CFR reference
21 CFR 436
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1995-05-23
Effective date
1995-06-22
HHS docket
Docket No. 94N-0352
Abstract
The Food and Drug Administration (FDA) is amending the antibiotic drug regulations to include the accepted standards for cefuroxime axetil for its use in a new dosage form of cefuroxime axetil, cefuroxime axetil for oral suspension. The manufacturer has supplied sufficient data and information to establish its safety and efficacy. DATES: Effective June 22, 1995; written comments, notice of participation, and requests for a hearing by June 22, 1995; data, information, and analyses to justify a hearing by July 24, 1995.