APPLICATION
ANDA072668
TYPE
ANDA
ORIGINAL APPROVAL
1990-06-08
LATEST ACTION
2003-08-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Prescription
Products
TIMOLOL MALEATEDiscontinued
TIMOLOL MALEATE 5MG · TABLET · ORAL
TIMOLOL MALEATEPrescription
TIMOLOL MALEATE 10MG · TABLET · ORAL
TIMOLOL MALEATEDiscontinued
TIMOLOL MALEATE 20MG · TABLET · ORAL
Approval history
2003-08-14Labeling · Supplement 12AP
2003-06-06Labeling · Supplement 11AP
2001-01-17Labeling · Supplement 10AP
1999-10-01Labeling · Supplement 9AP
1999-04-23Manufacturing (CMC) · Supplement 8AP
1998-02-05Manufacturing (CMC) · Supplement 7AP
1995-09-06Labeling · Supplement 6AP
1993-11-16Manufacturing (CMC) · Supplement 5AP
1993-05-14Labeling · Supplement 3AP
1992-07-10Labeling · Supplement 2AP
1991-07-10Manufacturing (CMC) · Supplement 1AP
1990-06-08OriginalAP
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.
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