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FDA NDA · NDA021493

ZYMAR

Sponsor: ALLERGAN

APPLICATION
NDA021493
TYPE
NDA
ORIGINAL APPROVAL
2003-03-28
LATEST ACTION
2017-03-21
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued

Products

ZYMAR · ReferenceDiscontinued
GATIFLOXACIN 0.3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION/DROPS · OPHTHALMIC

Approval history

2017-03-21Efficacy · Supplement 9 · priority — Pediatric Medical Review ↗AP
2017-03-21Labeling · Supplement 11 · standard — Label ↗AP
2015-05-21Labeling · Supplement 10 · standard — Label ↗AP
2005-06-20Labeling · Supplement 7 · standard — Label ↗AP
2005-06-20Manufacturing (CMC) · Supplement 6 · standard — Letter ↗AP
2004-07-23Labeling · Supplement 5 · standardAP
2003-03-28Type 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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