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FDA NDA · NDA065430

CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER

Sponsor: B BRAUN

APPLICATION
NDA065430
TYPE
NDA
ORIGINAL APPROVAL
2007-08-09
LATEST ACTION
2020-01-30
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER · ReferenceDiscontinued
CEFOTETAN DISODIUM EQ 2GM BASE/VIAL · INJECTABLE · INJECTION
CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER · ReferenceDiscontinued
CEFOTETAN DISODIUM EQ 1GM BASE/VIAL · INJECTABLE · INJECTION

Approval history

2020-01-30Labeling · Supplement 9 · standard — Label ↗AP
2013-12-18Manufacturing (CMC) · Supplement 6AP
2007-08-09UNKNOWN · Original · unknown — Letter ↗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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