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FDA NDA · NDA050780

CEFUROXIME AND DEXTROSE

Sponsor: B BRAUN

APPLICATION
NDA050780
TYPE
NDA
ORIGINAL APPROVAL
2001-02-21
LATEST ACTION
2020-12-05
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER · ReferenceDiscontinued
CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL · INJECTABLE · INJECTION
CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER · ReferenceDiscontinued
CEFUROXIME SODIUM EQ 750MG BASE/VIAL · INJECTABLE · INJECTION

Approval history

2020-12-05Labeling · Supplement 20 · standard — Letter ↗AP
2015-05-01Labeling · Supplement 19 · standard — Label ↗AP
2013-12-12Manufacturing (CMC) · Supplement 18 · standardAP
2007-09-10Labeling · Supplement 11 · standard — Letter ↗AP
2005-05-06Labeling · Supplement 8 · standard — Letter ↗AP
2004-06-29Labeling · Supplement 6 · standard — Letter ↗AP
2003-08-18Labeling · Supplement 5 · standard — Letter ↗AP
2001-02-21Type 5 - New Formulation or New Manufacturer · 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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