APPLICATION
ANDA074747
TYPE
ANDA
ORIGINAL APPROVAL
1997-03-25
LATEST ACTION
2020-04-03
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription
Products
TIMOLOL MALEATEPrescription
TIMOLOL MALEATE EQ 0.5% BASE · SOLUTION/DROPS · OPHTHALMIC
Approval history
2020-04-03Labeling · Supplement 17 · standardAP
2015-10-06Labeling · Supplement 14 · standardAP
2005-04-08Labeling · Supplement 12AP
2003-07-14Labeling · Supplement 10AP
2002-11-15Manufacturing (CMC) · Supplement 9AP
2002-07-03Manufacturing (CMC) · Supplement 8AP
2002-01-07Manufacturing (CMC) · Supplement 5AP
2001-08-15Manufacturing (CMC) · Supplement 4AP
2000-12-08Manufacturing (CMC) · Supplement 3AP
2000-03-29Labeling · Supplement 2AP
1997-12-16Manufacturing (CMC) · 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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