Orange Book product · Brand (NDA)

CAMBIA

DICLOFENAC POTASSIUM

Brand (NDA)NDA 022165TE ABRX ASSERTIO SPECLTY

Jun 17, 2009

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jun 17, 2009
17 yr 3 mo ago
Patent 7759394 expires
Listed drug substance patent expiration.
Jun 16, 2026
3 d ago
Patent 8097651 expires
Listed drug substance patent expiration.
Jun 16, 2026
3 d ago
Patent 8927604 expires
Listed method-of-use patent (U-436) expiration.
Jun 16, 2026
3 d ago
Patent 9827197 expires
Listed drug product patent expiration.
Jun 16, 2026
3 d ago
Today

Active ingredient

DICLOFENAC POTASSIUM

Strength

50MG

Dosage form

FOR SOLUTION

Route

ORAL

TE code

Application

NDA 022165

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
7759394	Jun 16, 2026	3 d ago	SubstanceProductU-436
8097651	Jun 16, 2026	3 d ago	SubstanceProductU-436
8927604	Jun 16, 2026	3 d ago	U-436
9827197	Jun 16, 2026	3 d ago	Product