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FDA NDA · NDA050694

CEFOTAN IN PLASTIC CONTAINER

Sponsor: PAI HOLDINGS PHARM

APPLICATION
NDA050694
TYPE
NDA
ORIGINAL APPROVAL
1993-07-30
LATEST ACTION
1995-10-20
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

CEFOTAN IN PLASTIC CONTAINERDiscontinued
CEFOTETAN DISODIUM EQ 40MG BASE/ML · INJECTABLE · INJECTION
CEFOTAN IN PLASTIC CONTAINERDiscontinued
CEFOTETAN DISODIUM EQ 20MG BASE/ML · INJECTABLE · INJECTION

Approval history

1995-10-20Labeling · Supplement 3 · standardAP
1995-01-09Manufacturing (CMC) · Supplement 1 · standardAP
1993-07-30Type 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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