APPLICATION
ANDA084553
TYPE
ANDA
ORIGINAL APPROVAL
1975-09-23
LATEST ACTION
1983-08-17
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
COMPOUND 65Discontinued
ASPIRIN 389MG, CAFFEINE 32.4MG, PROPOXYPHENE HYDROCHLORIDE 65MG · CAPSULE · ORAL
Approval history
1983-08-17Manufacturing (CMC) · Supplement 17AP
1983-04-28Manufacturing (CMC) · Supplement 15AP
1975-09-23OriginalAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.