← FDA DRUG APPROVALS

FDA ANDA · ANDA080044

PROPOXYPHENE COMPOUND 65

Sponsor: SANDOZ

APPLICATION
ANDA080044
TYPE
ANDA
ORIGINAL APPROVAL
1970-12-22
LATEST ACTION
1983-09-16
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

PROPOXYPHENE COMPOUND 65 · ReferenceDiscontinued
ASPIRIN 389MG, CAFFEINE 32.4MG, PROPOXYPHENE HYDROCHLORIDE 65MG · CAPSULE · ORAL

Approval history

1983-09-16Manufacturing (CMC) · Supplement 176AP
1983-09-16Manufacturing (CMC) · Supplement 177AP
1970-12-22OriginalAP
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 →