FABIOR
These highlights do not include all the information needed to use FABIOR Foam safely and effectively. See full prescribing information for FABIOR Foam.FABIOR (tazarotene) Foam, 0 .1%, for topical use Initial U.S. Approval: 1997
Approved
Approval ID
ae0afed7-1d60-45fd-a08b-8db094618521
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 28, 2023
Manufacturers
FDA
Mayne Pharma
DUNS: 867220261
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 Code51862-295
Application NumberNDA202428
Product Classification
M
Marketing Category
C73594
G
Generic Name
tazarotene
Product Specifications
Route of AdministrationTOPICAL
Effective DateFebruary 28, 2023
FDA Product Classification
INGREDIENTS (10)
tazaroteneActive
Quantity: 1 mg in 1 g
Code: 81BDR9Y8PS
Classification: ACTIB
CETEARETH-12Inactive
Code: 7V4MR24V5P
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
POTASSIUM CITRATEInactive
Code: EE90ONI6FF
Classification: IACT
DIISOPROPYL ADIPATEInactive
Code: P7E6YFV72X
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LIGHT MINERAL OILInactive
Code: N6K5787QVP
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT