APPLICATION
ANDA071288
TYPE
ANDA
ORIGINAL APPROVAL
1986-10-22
LATEST ACTION
2023-01-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PROPRANOLOL HYDROCHLORIDEDiscontinued
PROPRANOLOL HYDROCHLORIDE 90MG · TABLET · ORAL
Approval history
2023-01-10Labeling · Supplement 15 · standardAP
1991-11-13Labeling · Supplement 14AP
1991-04-23Labeling · Supplement 13AP
1989-09-06Labeling · Supplement 12AP
1988-03-04Manufacturing (CMC) · Supplement 11AP
1988-01-04Manufacturing (CMC) · Supplement 10AP
1988-01-04Manufacturing (CMC) · Supplement 9AP
1987-08-27Manufacturing (CMC) · Supplement 8AP
1987-05-04Manufacturing (CMC) · Supplement 3AP
1987-05-04Manufacturing (CMC) · Supplement 2AP
1986-12-18Manufacturing (CMC) · Supplement 1AP
1986-10-22OriginalAP
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.