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
fa5caf83-29d5-8229-b125-d7736928f132
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 29, 2023
Manufacturers
FDA
Cosette Pharmaceuticals, Inc.
DUNS: 116918230
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tazarotene
PRODUCT DETAILS
NDC Product Code0713-0670
Application NumberANDA208662
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateNovember 29, 2023
Generic NameTazarotene
INGREDIENTS (11)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: HHT01ZNK31
Classification: IACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 71DD5V995L
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM THIOSULFATEInactive
Code: HX1032V43M
Classification: IACT
SORBITAN MONOOLEATEInactive
Code: 06XEA2VD56
Classification: IACT
TAZAROTENEActive
Quantity: 1 mg in 1 g
Code: 81BDR9Y8PS
Classification: ACTIB