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FDA NDA · NDA050817

CEFEPIME

Sponsor: BAXTER HLTHCARE

APPLICATION
NDA050817
TYPE
NDA
ORIGINAL APPROVAL
2008-08-05
LATEST ACTION
2026-06-25
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

CEFEPIME IN PLASTIC CONTAINER · ReferencePrescription
CEFEPIME HYDROCHLORIDE EQ 2GM BASE/100ML (EQ 20MG BASE/ML) · INJECTABLE · INJECTION
CEFEPIME IN PLASTIC CONTAINER · ReferencePrescription
CEFEPIME HYDROCHLORIDE EQ 1GM BASE/50ML (EQ 20MG BASE/ML) · INJECTABLE · INJECTION

Approval history

2026-06-25Labeling · Supplement 15 · standard — Letter ↗AP
2025-07-29Labeling · Supplement 12 · standard — Label ↗AP
2020-05-01Labeling · Supplement 8 · standard — Label ↗AP
2016-05-09Labeling · Supplement 7 · standard — Label ↗AP
2014-06-04Labeling · Supplement 3 · standard — Label ↗AP
2012-09-06Labeling · Supplement 4 · standard — Letter ↗AP
2010-06-30Labeling · Supplement 1 · unknown — Label ↗AP
2008-08-05Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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