LEFLUNOMIDE
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Approved
Approval ID
8b365514-c859-ff93-e053-2a95a90ac698
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
Manufacturers
FDA
AvKARE
DUNS: 796560394
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
LEFLUNOMIDE
PRODUCT DETAILS
NDC Product Code42291-421
Application NumberANDA077090
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 9, 2024
Generic NameLEFLUNOMIDE
INGREDIENTS (5)
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LEFLUNOMIDEActive
Quantity: 20 mg in 1 1
Code: G162GK9U4W
Classification: ACTIB
LEFLUNOMIDE
PRODUCT DETAILS
NDC Product Code42291-420
Application NumberANDA077090
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 9, 2024
Generic NameLEFLUNOMIDE
INGREDIENTS (5)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LEFLUNOMIDEActive
Quantity: 10 mg in 1 1
Code: G162GK9U4W
Classification: ACTIB