Orange Book product · Brand (NDA)

FABIOR

TAZAROTENE

Brand (NDA)NDA 202428RX MAYNE PHARMA

May 11, 2012

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
May 11, 2012
14 yr 4 mo ago
Today
Patent 10568859 expires
Listed drug product patent expiration.
Feb 24, 2030
in 3 yr 9 mo
Patent 10688071 expires
Listed drug product patent expiration.
Feb 24, 2030
in 3 yr 9 mo
Patent 8808716 expires
Listed drug product patent expiration.
Feb 24, 2030
in 3 yr 9 mo

Active ingredient

TAZAROTENE

Strength

0.1%

Dosage form

AEROSOL, FOAM

Route

TOPICAL

TE code

Not listed

Application

NDA 202428

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
10568859	Feb 24, 2030	in 3 yr 9 mo	ProductU-2760
10688071	Feb 24, 2030	in 3 yr 9 mo	ProductU-2760
8808716	Feb 24, 2030	in 3 yr 9 mo	Product