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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code81672-5051
Application NumberNDA215272
Product Classification
M
Marketing Category
C73594
G
Generic Name
tapinarof
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 22, 2023
FDA Product Classification
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