← FDA DRUG APPROVALS

FDA ANDA · ANDA088725

CHLORPROPAMIDE

Sponsor: RISING

APPLICATION
ANDA088725
TYPE
ANDA
ORIGINAL APPROVAL
1984-08-31
LATEST ACTION
1999-12-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

CHLORPROPAMIDEDiscontinued
CHLORPROPAMIDE 100MG · TABLET · ORAL

Approval history

1999-12-14Manufacturing (CMC) · Supplement 17AP
1994-12-30Manufacturing (CMC) · Supplement 14AP
1989-02-15Bioequivalence · Supplement 15AP
1986-08-07Manufacturing (CMC) · Supplement 7AP
1986-08-07Manufacturing (CMC) · Supplement 5AP
1986-08-07Manufacturing (CMC) · Supplement 6AP
1986-08-07Manufacturing (CMC) · Supplement 4AP
1986-01-15Manufacturing (CMC) · Supplement 3AP
1985-01-07Manufacturing (CMC) · Supplement 2AP
1984-08-31OriginalAP
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 →