Orange Book product · Brand (NDA)
TAZORAC
TAZAROTENE
At a glance
Sep 29, 2000
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 29, 2000
26 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
TAZAROTENE
Strength
0.1%
Dosage form
CREAM
Route
TOPICAL
TE code
AB
Application
NDA 021184
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2019ARAZLOBrand (NDA)
NDA 211882 · BAUSCH
- 2012FABIORBrand (NDA)
NDA 202428 · MAYNE PHARMA
- 1997TAZORACBrand (NDA)
NDA 020600 · ALMIRALL
- 2025TAZAROTENEGeneric (ANDA)
ANDA 214560 · SOLARIS PHARMA CORP
- 2025TAZAROTENEGeneric (ANDA)
ANDA 215393 · PADAGIS ISRAEL
- 2025TAZAROTENEGeneric (ANDA)
ANDA 208662 · COSETTE PHARMS NC
- 2024TAZAROTENEGeneric (ANDA)
ANDA 217075 · PADAGIS ISRAEL
- 2023TAZAROTENEGeneric (ANDA)
ANDA 213079 · PADAGIS ISRAEL
- 2023TAZAROTENEGeneric (ANDA)
ANDA 213644 · SOLARIS PHARMA CORP
- 2022TAZAROTENEGeneric (ANDA)
ANDA 215433 · COSETTE PHARMS NC
- 2022TAZAROTENEGeneric (ANDA)
ANDA 214136 · COSETTE PHARMS NC
- 2019TAZAROTENEGeneric (ANDA)
ANDA 211175 · FOUGERA PHARMS INC
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
