Orange Book product · Brand (NDA)

PENNSAID

DICLOFENAC SODIUM

Brand (NDA)NDA 020947DISCN NUVO PHARMS INC

Nov 04, 2009

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Nov 04, 2009
16 yr 10 mo ago
Today
Patent 8217078 expires
Listed method-of-use patent (U-1248) expiration.
Jul 10, 2029
in 3 yr 1 mo
Patent 8618164 expires
Listed method-of-use patent (U-1477) expiration.
Jul 10, 2029
in 3 yr 1 mo
Patent 8741956 expires
Listed method-of-use patent (U-1435) expiration.
Jul 10, 2029
in 3 yr 1 mo
Patent 8546450 expires
Listed method-of-use patent (U-1435) expiration.
Aug 09, 2030
in 4 yr 2 mo
Patent 8546450 expires
Listed method-of-use patent (U-1436) expiration.
Aug 09, 2030
in 4 yr 2 mo

Active ingredient

DICLOFENAC SODIUM

Strength

1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

SOLUTION

Route

TOPICAL

TE code

Not listed

Application

NDA 020947

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

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
8217078	Jul 10, 2029	in 3 yr 1 mo	U-1248
8618164	Jul 10, 2029	in 3 yr 1 mo	U-1477
8741956	Jul 10, 2029	in 3 yr 1 mo	U-1435
8546450	Aug 09, 2030	in 4 yr 2 mo	U-1435
8546450	Aug 09, 2030	in 4 yr 2 mo	U-1436