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FDA NDA · NDA020963

TIMOLOL GFS

timolol maleate

Sponsor: SANDOZ

APPLICATION
NDA020963
TYPE
NDA
ORIGINAL APPROVAL
1998-10-21
LATEST ACTION
2024-05-28
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION, GEL FORMING/DROPS
MARKETING STATUS
Prescription

Products

TIMOLOL MALEATE · ReferencePrescription
TIMOLOL MALEATE EQ 0.25% BASE · SOLUTION, GEL FORMING/DROPS · OPHTHALMIC
TIMOLOL MALEATE · ReferencePrescription
TIMOLOL MALEATE EQ 0.5% BASE · SOLUTION, GEL FORMING/DROPS · OPHTHALMIC

Approval history

2024-05-28Labeling · Supplement 15 · standard — Letter ↗AP
2014-09-25Manufacturing (CMC) · Supplement 12 · standardAP
2007-06-08Efficacy · Supplement 10 · priority — Letter ↗AP
2003-07-02Labeling · Supplement 7 · standard — Label ↗AP
2001-02-05Labeling · Supplement 5 · standard — Label ↗AP
2000-03-09Labeling · Supplement 4 · standardAP
2000-02-18Manufacturing (CMC) · Supplement 3 · standardAP
1999-10-06Manufacturing (CMC) · Supplement 1 · standardAP
1999-08-17Manufacturing (CMC) · Supplement 2 · standardAP
1998-10-21Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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