Orange Book product · Brand (NDA)

ZILRETTA

TRIAMCINOLONE ACETONIDE

Brand (NDA)NDA 208845RX PACIRA PHARMS INC

Oct 06, 2017

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Oct 06, 2017
8 yr 10 mo ago
Today
Patent 8828440 expires
Listed drug product patent expiration.
Aug 04, 2031
in 5 yr 2 mo
Patent 9555048 expires
Listed method-of-use patent (U-2151) expiration.
Aug 04, 2031
in 5 yr 2 mo

Active ingredient

TRIAMCINOLONE ACETONIDE

Strength

32MG/VIAL

Dosage form

FOR SUSPENSION, EXTENDED RELEASE

Route

INTRA-ARTICULAR

TE code

Not listed

Application

NDA 208845

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
8828440	Aug 04, 2031	in 5 yr 2 mo	Product
9555048	Aug 04, 2031	in 5 yr 2 mo	U-2151