Orange Book product · Brand (NDA)

ARAZLO

TAZAROTENE

Brand (NDA)NDA 211882RX BAUSCH

Dec 18, 2019

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Dec 18, 2019
6 yr 7 mo ago
Today
Patent 11679116 expires
Listed drug product patent expiration.
Jun 06, 2036
in 10 yr 1 mo
Patent 11311482 expires
Listed method-of-use patent (U-2368) expiration.
May 11, 2038
in 12 yr 1 mo
Patent 12128137 expires
Listed drug product patent expiration.
May 11, 2038
in 12 yr 1 mo

Active ingredient

TAZAROTENE

Strength

0.045%

Dosage form

LOTION

Route

TOPICAL

TE code

Not listed

Application

NDA 211882

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
11679116	Jun 06, 2036	in 10 yr 1 mo	Product
11311482	May 11, 2038	in 12 yr 1 mo	U-2368
12128137	May 11, 2038	in 12 yr 1 mo	ProductU-2368