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Targretin

These highlights do not include all the information needed to use TARGRETIN safely and effectively. See full prescribing information for TARGRETIN.TARGRETIN (bexarotene) capsules, for oral useInitial U.S. Approval: 1999

Approved
Approval ID

1d056725-0576-4338-8089-6336e768ccdc

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 30, 2020

Manufacturers
FDA

Bausch Health US, LLC

DUNS: 831922468

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 Code0187-5526
Application NumberNDA021055
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateApril 30, 2020
Generic Namebexarotene

INGREDIENTS (12)

BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
BEXAROTENEActive
Quantity: 75 mg in 1 1
Code: A61RXM4375
Classification: ACTIB
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
1,4-SORBITANInactive
Code: AV0YTZ4E6J
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT

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Targretin - FDA Drug Approval Details