MedPath

Targretin

Targretin (bexarotene) gel 1% Rx only

Approved
Approval ID

d35b4697-3f3b-4aa1-b5d9-153993e83811

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 3, 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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0187-5525
Application NumberNDA021056
Product Classification
M
Marketing Category
C73594
G
Generic Name
bexarotene
Product Specifications
Route of AdministrationTOPICAL
Effective DateFebruary 3, 2020
FDA Product Classification

INGREDIENTS (5)

BEXAROTENEActive
Quantity: 1 g in 100 g
Code: A61RXM4375
Classification: ACTIB
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT

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Targretin - FDA Drug Approval Details