APPLICATION
ANDA074516
TYPE
ANDA
ORIGINAL APPROVAL
1997-03-25
LATEST ACTION
2002-03-21
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
TIMOLOL MALEATEDiscontinued
TIMOLOL MALEATE EQ 0.5% BASE · SOLUTION/DROPS · OPHTHALMIC
Approval history
2002-03-21Manufacturing (CMC) · Supplement 6AP
1999-11-22Labeling · Supplement 5AP
1999-07-06Manufacturing (CMC) · Supplement 4AP
1999-06-07Manufacturing (CMC) · Supplement 3AP
1999-01-28Labeling · Supplement 2AP
1998-02-12Labeling · Supplement 1AP
1997-03-25OriginalAP
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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