APPLICATION
ANDA074261
TYPE
ANDA
ORIGINAL APPROVAL
1995-04-28
LATEST ACTION
2022-11-22
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription
Products
TIMOLOL MALEATEPrescription
TIMOLOL MALEATE EQ 0.25% BASE · SOLUTION/DROPS · OPHTHALMIC
Approval history
2022-11-22Labeling · Supplement 24 · standardAP
2022-11-22Labeling · Supplement 27 · standardAP
2005-04-08Labeling · Supplement 17AP
2004-05-21Labeling · Supplement 16AP
2003-03-21Labeling · Supplement 14AP
2002-10-01Manufacturing (CMC) · Supplement 13AP
2002-03-28Manufacturing (CMC) · Supplement 12AP
2002-03-05Labeling · Supplement 11AP
2000-04-28Manufacturing (CMC) · Supplement 9AP
2000-04-07Manufacturing (CMC) · Supplement 10AP
1999-08-27Labeling · Supplement 8AP
1999-07-28Manufacturing (CMC) · Supplement 5AP
1999-05-07Manufacturing (CMC) · Supplement 6AP
1999-03-23Manufacturing (CMC) · Supplement 7AP
1998-07-27Manufacturing (CMC) · Supplement 3AP
1998-07-27Manufacturing (CMC) · Supplement 2AP
1998-02-20Manufacturing (CMC) · Supplement 4AP
1995-08-04Manufacturing (CMC) · Supplement 1AP
1995-04-28OriginalAP
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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