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
NDC Product Code0713-0804
Application NumberANDA214136
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateNovember 29, 2023
Generic Nametazarotene
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