← FDA DRUG APPROVALS

FDA ANDA · ANDA085511

CAM-METRAZINE

Sponsor: ABC HOLDING

APPLICATION
ANDA085511
TYPE
ANDA
ORIGINAL APPROVAL
1977-05-06
LATEST ACTION
1989-12-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

CAM-METRAZINEDiscontinued
PHENDIMETRAZINE TARTRATE 35MG · TABLET · ORAL

Approval history

1989-12-13Labeling · Supplement 21AP
1988-06-27Manufacturing (CMC) · Supplement 20AP
1984-06-12Manufacturing (CMC) · Supplement 15AP
1984-06-12Manufacturing (CMC) · Supplement 18AP
1983-06-17Manufacturing (CMC) · Supplement 12AP
1983-06-09Manufacturing (CMC) · Supplement 9AP
1983-06-09Manufacturing (CMC) · Supplement 11AP
1983-02-11Manufacturing (CMC) · Supplement 10AP
1977-05-06OriginalAP
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 →