APPLICATION
ANDA075412
TYPE
ANDA
ORIGINAL APPROVAL
2000-09-08
LATEST ACTION
2023-08-09
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
TIMOLOL MALEATEDiscontinued
TIMOLOL MALEATE EQ 0.5% BASE · SOLUTION/DROPS · OPHTHALMIC
Approval history
2023-08-09Labeling · Supplement 31 · standardAP
2020-04-03Labeling · Supplement 30 · standardAP
2015-03-17Labeling · Supplement 21AP
2007-02-10Labeling · Supplement 16AP
2004-01-14Labeling · Supplement 9AP
2002-12-23Labeling · Supplement 4AP
2002-03-15Labeling · Supplement 3AP
2001-07-30Manufacturing (CMC) · Supplement 2AP
2001-03-06Manufacturing (CMC) · Supplement 1AP
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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