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FDA Orange Book · active-ingredient family

Tazarotene

Tazarotene is approved as 4 brand and 10 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ARAZLO · NDA 211882

4

Brand (NDA)

10

Generics (ANDA)

6

Listed patents

0

Exclusivity periods

Brand (NDA) products · aerosol, foam, cream, gel, lotion

ProductApplicantApplicationTEApproved
ARAZLORLDBAUSCHNDA 211882—Dec 18, 2019
FABIORRLDMAYNE PHARMANDA 202428—May 11, 2012
AVAGERLD×3ALMIRALLNDA 021184ABSep 30, 2002
TAZORACRLD×2ALMIRALLNDA 020600ABJun 13, 1997

Generic (ANDA) products (10)

ProductApplicantApplicationTEApproved
TAZAROTENESOLARIS PHARMA CORPANDA 214560ABNov 24, 2025
TAZAROTENEPADAGIS ISRAELANDA 215393—Jul 29, 2025
TAZAROTENE×2COSETTE PHARMS NCANDA 208662ABMar 10, 2025
TAZAROTENEPADAGIS ISRAELANDA 217075ABJul 15, 2024
TAZAROTENE×2PADAGIS ISRAELANDA 213079ABApr 25, 2023
TAZAROTENE×2SOLARIS PHARMA CORPANDA 213644ABMar 20, 2023
TAZAROTENECOSETTE PHARMS NCANDA 215433ABSep 13, 2022
TAZAROTENECOSETTE PHARMS NCANDA 214136ABSep 13, 2022
TAZAROTENEFOUGERA PHARMS INCANDA 211175—Jan 28, 2019
TAZAROTENESUN PHARMA CANADAANDA 208258ABApr 03, 2017

Listed patents (6)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10568859Feb 24, 2030in 3 yr 9 mo
ProductU-2760
10688071Feb 24, 2030in 3 yr 9 mo
ProductU-2760
8808716Feb 24, 2030in 3 yr 9 mo
Product
11679116Jun 06, 2036in 10 yr 1 mo
Product
11311482May 11, 2038in 12 yr 1 mo
U-2368
12128137May 11, 2038in 12 yr 1 mo
ProductU-2368

Tazarotene — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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