← FDA DRUG APPROVALS

FDA ANDA · ANDA085694

PHENDIMETRAZINE TARTRATE

Sponsor: SANDOZ

APPLICATION
ANDA085694
TYPE
ANDA
ORIGINAL APPROVAL
1978-06-05
LATEST ACTION
1995-07-19
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

PHENDIMETRAZINE TARTRATEDiscontinued
PHENDIMETRAZINE TARTRATE 35MG · CAPSULE · ORAL

Approval history

1995-07-19Manufacturing (CMC) · Supplement 17AP
1988-12-06Labeling · Supplement 16AP
1985-06-13Manufacturing (CMC) · Supplement 14AP
1982-08-30Manufacturing (CMC) · Supplement 11AP
1982-08-10Manufacturing (CMC) · Supplement 8AP
1982-05-24Manufacturing (CMC) · Supplement 10AP
1982-05-24Manufacturing (CMC) · Supplement 9AP
1982-05-24Manufacturing (CMC) · Supplement 6AP
1978-06-05OriginalAP
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 →