APPLICATION
ANDA072552
TYPE
ANDA
ORIGINAL APPROVAL
1989-04-13
LATEST ACTION
2000-12-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TIMOLOL MALEATEDiscontinued
TIMOLOL MALEATE 20MG · TABLET · ORAL
Approval history
2000-12-13Manufacturing (CMC) · Supplement 8AP
1999-05-05Manufacturing (CMC) · Supplement 7AP
1997-10-14Labeling · Supplement 6AP
1996-11-18Manufacturing (CMC) · Supplement 5AP
1995-04-17Manufacturing (CMC) · Supplement 4AP
1993-08-05Labeling · Supplement 3AP
1993-07-27Manufacturing (CMC) · Supplement 2AP
1992-02-28Labeling · Supplement 1AP
1989-04-13OriginalAP
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.