TAZAROTENE
These highlights do not include all the information needed to use TAZAROTENE GEL safely and effectively. See full prescribing information for TAZAROTENE GEL. TAZAROTENE gel, 0.1%, for topical use Initial U.S. Approval: 1997
Approved
Approval ID
94749b8e-0d00-4257-a660-6d0fc8815fcf
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0713-0804
Application NumberANDA214136
Product Classification
M
Marketing Category
C73584
G
Generic Name
tazarotene
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 29, 2023
FDA Product Classification
INGREDIENTS (13)
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT
TAZAROTENEActive
Quantity: 1 mg in 1 g
Code: 81BDR9Y8PS
Classification: ACTIB
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: HHT01ZNK31
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
HEXYLENE GLYCOLInactive
Code: KEH0A3F75J
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYSORBATE 40Inactive
Code: STI11B5A2X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT