TAZAROTENE
These highlights do not include all the information needed to use TAZAROTENE CREAM safely and effectively. See full prescribing information for TAZAROTENE CREAM.TAZAROTENE cream, for topical use Initial U.S. Approval: 1997
Approved
Approval ID
10ac61b3-cf91-4d83-b253-e9b0b22567ac
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 14, 2020
Manufacturers
FDA
Fougera Pharmaceuticals Inc.
DUNS: 043838424
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
tazarotene
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0168-0454
Application NumberANDA211175
Product Classification
M
Marketing Category
C73584
G
Generic Name
tazarotene
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 27, 2018
FDA Product Classification
INGREDIENTS (11)
tazaroteneActive
Quantity: 1 mg in 1 g
Code: 81BDR9Y8PS
Classification: ACTIB
waterInactive
Code: 059QF0KO0R
Classification: IACT
edetate disodiumInactive
Code: 7FLD91C86K
Classification: IACT
sodium thiosulfateInactive
Code: HX1032V43M
Classification: IACT
mineral oilInactive
Code: T5L8T28FGP
Classification: IACT
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 809Y72KV36
Classification: IACT
Benzyl alcoholInactive
Code: LKG8494WBH
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
sorbitan monooleateInactive
Code: 06XEA2VD56
Classification: IACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: HHT01ZNK31
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT