Orange Book product · Brand (NDA)

DYLOJECT

DICLOFENAC SODIUM

Brand (NDA)NDA 022396DISCN JAVELIN PHARMS INC

Dec 23, 2014

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Dec 23, 2014
11 yr 8 mo ago
Today
Patent 8946292 expires
Listed method-of-use patent (U-1659) expiration.
Mar 22, 2027
in 9 mo

Active ingredient

DICLOFENAC SODIUM

Strength

37.5MG/ML (37.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 022396

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
8946292	Mar 22, 2027	in 9 mo	U-1659