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FDA NDA · NDA050792

CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER

Sponsor: B BRAUN

APPLICATION
NDA050792
TYPE
NDA
ORIGINAL APPROVAL
2004-07-29
LATEST ACTION
2007-09-10
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINERDiscontinued
CEFOTAXIME SODIUM EQ 2GM BASE · INJECTABLE · INJECTION
CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINERDiscontinued
CEFOTAXIME SODIUM EQ 1GM BASE · INJECTABLE · INJECTION

Approval history

2007-09-10Labeling · Supplement 2 · standardLetterAP
2004-07-29Type 5 - New Formulation or New Manufacturer · Original · standardLabelAP
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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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