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LEFLUNOMIDE

{'content': [{'@styleCode': 'bold', 'content': [{'@styleCode': 'bold', '#text': 'These highlights do not include all the information needed to use LEFLUNOMIDE TABLETS safely and effectively. See full prescribing information for LEFLUNOMIDE TABLETS.'}, {'@styleCode': 'bold', 'br': None, '#text': 'LEFLUNOMIDE tablets, for oral use Initial U.S. Approval: 1998'}], 'br': [None, None, None]}, {'@styleCode': 'bold'}], 'br': [None, None]}

Approved
Approval ID

753453c5-8a7a-878e-3ce7-1d1edce718a9

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 14, 2023

Manufacturers
FDA

Apotex Corp.

DUNS: 845263701

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 Code60505-2502
Application NumberANDA077090
Product Classification
M
Marketing Category
C73584
G
Generic Name
LEFLUNOMIDE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 14, 2023
FDA Product Classification

INGREDIENTS (5)

LEFLUNOMIDEActive
Quantity: 10 mg in 1 1
Code: G162GK9U4W
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

LEFLUNOMIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code60505-2503
Application NumberANDA077090
Product Classification
M
Marketing Category
C73584
G
Generic Name
LEFLUNOMIDE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 14, 2023
FDA Product Classification

INGREDIENTS (5)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LEFLUNOMIDEActive
Quantity: 20 mg in 1 1
Code: G162GK9U4W
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT

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LEFLUNOMIDE - FDA Drug Approval Details