bexarotene
These highlights do not include all the information needed to use BEXAROTENE CAPSULES safely and effectively. See full prescribing information for BEXAROTENE CAPSULES. BEXAROTENE capsules, for oral use Initial U.S. Approval: 1999
Approved
Approval ID
3292c63c-052f-4f28-b739-530a86e660bf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 10, 2021
Manufacturers
FDA
Actavis Pharma, Inc.
DUNS: 119723554
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 Code0591-2832
Application NumberANDA209931
Product Classification
M
Marketing Category
C73584
G
Generic Name
bexarotene
Product Specifications
Route of AdministrationORAL
Effective DateNovember 11, 2021
FDA Product Classification
INGREDIENTS (12)
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Polyvinyl Acetate PhthalateInactive
Code: 58QVG85GW3
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
BEXAROTENEActive
Quantity: 75 mg in 1 1
Code: A61RXM4375
Classification: ACTIB