← FDA DRUG APPROVALS

FDA NDA · NDA022548

ZYMAXID

gatifloxacin

Sponsor: ABBVIE

APPLICATION
NDA022548
TYPE
NDA
ORIGINAL APPROVAL
2010-05-18
LATEST ACTION
2016-09-08
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription

Products

ZYMAXID · ReferencePrescription
GATIFLOXACIN 0.5% · SOLUTION/DROPS · OPHTHALMIC

Approval history

2016-09-08Labeling · Supplement 2 · standard — Label ↗AP
2014-03-12Manufacturing (CMC) · Supplement 1 · standardAP
2010-05-18Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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