FDA NDA · NDA203491

ILEVRO

nepafenac

Sponsor: HARROW EYE

APPLICATION

NDA203491

TYPE

NDA

ORIGINAL APPROVAL

2012-10-16

LATEST ACTION

2015-11-10

ROUTE

OPHTHALMIC

DOSAGE FORM

SUSPENSION/DROPS

MARKETING STATUS

Prescription

Products

ILEVRO · ReferencePrescription

NEPAFENAC 0.3% · SUSPENSION/DROPS · OPHTHALMIC

2015-11-10Manufacturing (CMC) · Supplement 9 · standardAP

2015-09-28Manufacturing (CMC) · Supplement 8 · standardAP

2014-07-03Manufacturing (CMC) · Supplement 6 · standard — Letter ↗AP

2014-02-13Manufacturing (CMC) · Supplement 4 · standardAP

2014-02-05Manufacturing (CMC) · Supplement 3 · standardAP

2013-12-09Manufacturing (CMC) · Supplement 5 · standardAP

2012-12-14Labeling · Supplement 1 · standard — Letter ↗AP

2012-10-16Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗AP

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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