APPLICATION
ANDA073661
TYPE
ANDA
ORIGINAL APPROVAL
1993-10-31
LATEST ACTION
1997-07-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PINDOLOLDiscontinued
PINDOLOL 5MG · TABLET · ORAL
PINDOLOLDiscontinued
PINDOLOL 10MG · TABLET · ORAL
Approval history
1997-07-10Manufacturing (CMC) · Supplement 4AP
1997-01-31Manufacturing (CMC) · Supplement 3AP
1996-04-26Manufacturing (CMC) · Supplement 2AP
1994-09-15Manufacturing (CMC) · Supplement 1AP
1993-10-31OriginalAP
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.