leflunomide
These highlights do not include all the information needed to use LEFLUNOMIDE TABLETS, USPsafely and effectively. See full prescribing information for LEFLUNOMIDE TABLETS, USP.LEFLUNOMIDE tablets, USP for oral useInitial U.S. Approval: 1998
Approved
Approval ID
40dd071a-d07f-452f-bf1a-2a23b9d22ca4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 19, 2022
Manufacturers
FDA
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
DUNS: 780779901
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 Code23155-043
Application NumberANDA077086
Product Classification
M
Marketing Category
C73584
G
Generic Name
leflunomide
Product Specifications
Route of AdministrationORAL
Effective DateApril 19, 2022
FDA Product Classification
INGREDIENTS (7)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LEFLUNOMIDEActive
Quantity: 10 mg in 1 1
Code: G162GK9U4W
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
leflunomide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code23155-044
Application NumberANDA077086
Product Classification
M
Marketing Category
C73584
G
Generic Name
leflunomide
Product Specifications
Route of AdministrationORAL
Effective DateApril 19, 2022
FDA Product Classification
INGREDIENTS (7)
LEFLUNOMIDEActive
Quantity: 20 mg in 1 1
Code: G162GK9U4W
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT