← FDA DRUG APPROVALS

FDA ANDA · ANDA070310

PROPRANOLOL HYDROCHLORIDE

Sponsor: DURAMED PHARMS BARR

APPLICATION
ANDA070310
TYPE
ANDA
ORIGINAL APPROVAL
1985-09-09
LATEST ACTION
1990-01-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PROPRANOLOL HYDROCHLORIDEDiscontinued
PROPRANOLOL HYDROCHLORIDE 80MG · TABLET · ORAL

Approval history

1990-01-23Labeling · Supplement 20AP
1989-03-27Labeling · Supplement 15AP
1985-09-09OriginalAP
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 →