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FDA NDA · NDA021862

NEVANAC

nepafenac

Sponsor: HARROW EYE

APPLICATION
NDA021862
TYPE
NDA
ORIGINAL APPROVAL
2005-08-19
LATEST ACTION
2020-11-04
ROUTE
OPHTHALMIC
DOSAGE FORM
SUSPENSION/DROPS
MARKETING STATUS
Prescription

Products

NEVANAC · ReferencePrescription
NEPAFENAC 0.1% · SUSPENSION/DROPS · OPHTHALMIC

Approval history

2020-11-04Labeling · Supplement 17 · standard — Letter ↗AP
2017-12-15Labeling · Supplement 13 · standard — Letter ↗AP
2014-03-07Manufacturing (CMC) · Supplement 10 · priorityAP
2011-06-27Labeling · Supplement 8 · unknown — Letter ↗AP
2008-05-08Labeling · Supplement 2 · standard — Label ↗AP
2005-08-19Type 1 - New Molecular Entity · Original · priority — Review ↗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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