Bexarotene
Bexarotene Gel, 1% Rx Only
Approved
Approval ID
2c21f361-e3d1-45a5-a6e7-df8164e3f90d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 29, 2023
Manufacturers
FDA
Amneal Pharmaceuticals NY LLC
DUNS: 123797875
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Bexarotene
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69238-2088
Application NumberANDA215398
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bexarotene
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 29, 2023
FDA Product Classification
INGREDIENTS (5)
BEXAROTENEActive
Quantity: 10 mg in 1 g
Code: A61RXM4375
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT