APPLICATION
ANDA072502
TYPE
ANDA
ORIGINAL APPROVAL
1989-04-11
LATEST ACTION
1998-09-30
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
PROPRANOLOL HYDROCHLORIDEDiscontinued
PROPRANOLOL HYDROCHLORIDE 160MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
1998-09-30Labeling · Supplement 10AP
1998-06-16Labeling · Supplement 9AP
1998-03-09Manufacturing (CMC) · Supplement 8AP
1998-01-26Labeling · Supplement 7AP
1997-01-31Manufacturing (CMC) · Supplement 6AP
1993-05-18Bioequivalence · Supplement 4AP
1993-04-23Labeling · Supplement 5AP
1993-02-22Manufacturing (CMC) · Supplement 3AP
1990-11-20Manufacturing (CMC) · Supplement 1AP
1989-04-11OriginalAP
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.