VTAMA
These highlights do not include all the information needed to use VTAMA cream safely and effectively. See full prescribing information for VTAMA. VTAMA (tapinarof) cream, 1%, for topical use. Initial U.S. Approval: 2022
Approved
Approval ID
9309d20f-8cd4-4c96-93fa-7f730e83c7ab
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 22, 2023
Manufacturers
FDA
Dermavant Sciences, Inc.
DUNS: 080294355
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
tapinarof
PRODUCT DETAILS
NDC Product Code81672-5051
Application NumberNDA215272
Marketing CategoryC73594
Route of AdministrationTOPICAL
Effective DateDecember 22, 2023
Generic Nametapinarof
INGREDIENTS (14)
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
DIETHYLENE GLYCOL MONOETHYL ETHERInactive
Code: A1A1I8X02B
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
STEARETH-2Inactive
Code: V56DFE46J5
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POLAWAX POLYSORBATEInactive
Code: Q504PL8E0V
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
STEARETH-20Inactive
Code: L0Q8IK9E08
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TAPINAROFActive
Quantity: 10 mg in 1 g
Code: 84HW7D0V04
Classification: ACTIB