← FDA DRUG APPROVALS

FDA ANDA · ANDA085497

PHENDIMETRAZINE TARTRATE

Sponsor: VIRTUS

APPLICATION
ANDA085497
TYPE
ANDA
ORIGINAL APPROVAL
1977-08-19
LATEST ACTION
1995-07-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PHENDIMETRAZINE TARTRATEDiscontinued
PHENDIMETRAZINE TARTRATE 35MG · TABLET · ORAL

Approval history

1995-07-19Manufacturing (CMC) · Supplement 13AP
1995-07-19Manufacturing (CMC) · Supplement 12AP
1991-03-18Labeling · Supplement 15AP
1989-10-24Labeling · Supplement 11AP
1985-06-14Manufacturing (CMC) · Supplement 9AP
1982-08-12Manufacturing (CMC) · Supplement 6AP
1982-05-19Manufacturing (CMC) · Supplement 4AP
1977-08-19OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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 →