Orange Book product · Brand (NDA)

NEVANAC

NEPAFENAC

Brand (NDA)NDA 021862RX HARROW EYE

Aug 19, 2005

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Aug 19, 2005
21 yr 2 mo ago
Today
Patent 7834059 expires
Listed method-of-use patent (U-1095) expiration.
Jan 31, 2027
in 8 mo

Active ingredient

NEPAFENAC

Strength

0.1%

Dosage form

SUSPENSION/DROPS

Route

OPHTHALMIC

TE code

Not listed

Application

NDA 021862

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7834059	Jan 31, 2027	in 8 mo	U-1095