← FDA DRUG APPROVALS

FDA ANDA · ANDA073666

METOPROLOL TARTRATE

Sponsor: PHARMOBEDIENT

APPLICATION
ANDA073666
TYPE
ANDA
ORIGINAL APPROVAL
1993-12-21
LATEST ACTION
2001-02-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

METOPROLOL TARTRATEDiscontinued
METOPROLOL TARTRATE 100MG · TABLET · ORAL
METOPROLOL TARTRATEDiscontinued
METOPROLOL TARTRATE 50MG · TABLET · ORAL

Approval history

2001-02-08Manufacturing (CMC) · Supplement 5AP
1999-10-01Labeling · Supplement 4AP
1999-08-04Manufacturing (CMC) · Supplement 3AP
1998-02-05Manufacturing (CMC) · Supplement 2AP
1997-01-16Manufacturing (CMC) · Supplement 1AP
1993-12-21OriginalAP
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 →