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FDA NDA · NDA050821

CEFEPIME HYDROCHLORIDE AND DEXTROSE

cefepime hydrochloride

Sponsor: B BRAUN

APPLICATION
NDA050821
TYPE
NDA
ORIGINAL APPROVAL
2010-05-06
LATEST ACTION
2026-04-07
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER · ReferencePrescription
CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER · ReferencePrescription
CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL · INJECTABLE · INJECTION

Approval history

2026-04-07Labeling · Supplement 12 · standard — Letter ↗AP
2022-03-18Labeling · Supplement 6 · standard — Letter ↗AP
2015-11-09Labeling · Supplement 4 · standard — Label ↗AP
2014-06-06Labeling · Supplement 2 · standard — Label ↗AP
2012-09-06Labeling · Supplement 1 · standard — Label ↗AP
2010-05-06Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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