APPLICATION
ANDA074776
TYPE
ANDA
ORIGINAL APPROVAL
1997-03-25
LATEST ACTION
2002-12-09
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
TIMOLOL MALEATEDiscontinued
TIMOLOL MALEATE EQ 0.5% BASE · SOLUTION/DROPS · OPHTHALMIC
Approval history
2002-12-09Labeling · Supplement 18AP
2002-08-22Labeling · Supplement 17AP
2001-11-27Manufacturing (CMC) · Supplement 16AP
2001-03-07Manufacturing (CMC) · Supplement 15AP
2000-10-05Manufacturing (CMC) · Supplement 14AP
2000-06-27Manufacturing (CMC) · Supplement 13AP
2000-05-18Manufacturing (CMC) · Supplement 8AP
2000-05-15Manufacturing (CMC) · Supplement 12AP
2000-04-28Manufacturing (CMC) · Supplement 9AP
1999-08-24Labeling · Supplement 10AP
1999-06-07Manufacturing (CMC) · Supplement 7AP
1999-01-13Labeling · Supplement 6AP
1998-06-25Labeling · Supplement 5AP
1998-03-27Manufacturing (CMC) · Supplement 3AP
1998-03-06Manufacturing (CMC) · Supplement 1AP
1998-01-29Manufacturing (CMC) · Supplement 2AP
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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