MedPath

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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42291-421
Application NumberANDA077090
Product Classification
M
Marketing Category
C73584
G
Generic Name
LEFLUNOMIDE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2024
FDA Product Classification

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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42291-420
Application NumberANDA077090
Product Classification
M
Marketing Category
C73584
G
Generic Name
LEFLUNOMIDE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2024
FDA Product Classification

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

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