← FDA DRUG APPROVALS

FDA ANDA · ANDA063293

CEFOTAN

Sponsor: TELIGENT

APPLICATION
ANDA063293
TYPE
ANDA
ORIGINAL APPROVAL
1993-04-29
LATEST ACTION
1996-08-06
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

CEFOTANDiscontinued
CEFOTETAN DISODIUM EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
CEFOTANDiscontinued
CEFOTETAN DISODIUM EQ 2GM BASE/VIAL · INJECTABLE · INJECTION

Approval history

1996-08-06Labeling · Supplement 4AP
1994-10-11Manufacturing (CMC) · Supplement 3AP
1993-05-28Manufacturing (CMC) · Supplement 1AP
1993-04-29OriginalAP
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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →