Bexarotene
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 1999
Approved
Approval ID
2d1eb4bd-51f9-4c9b-9fb1-0be5e30a3dc5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 13, 2018
Manufacturers
FDA
Mylan Pharmaceuticals Inc.
DUNS: 059295980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Bexarotene
PRODUCT DETAILS
NDC Product Code0378-6955
Application NumberANDA203174
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 14, 2017
Generic NameBexarotene
INGREDIENTS (12)
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
BEXAROTENEActive
Quantity: 75 mg in 1 1
Code: A61RXM4375
Classification: ACTIB
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT