Leflunomide
Leflunomide Tablets, USP 10 mg and 20 mg These highlights do not include all the information needed to use LEFLUNOMIDE TABLETS safely and effectively. See full prescribing information for LEFLUNOMIDE TABLETS. LEFLUNOMIDE tablets, for oral use Initial U.S. Approval: 1998
Approved
Approval ID
006b5bf4-97c0-48dc-8e5e-3c6f64d7bdc1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 31, 2023
Manufacturers
FDA
Chartwell RX, LLC
DUNS: 079394054
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 Code62135-793
Application NumberANDA077086
Product Classification
M
Marketing Category
C73584
G
Generic Name
Leflunomide
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2023
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
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LEFLUNOMIDEActive
Quantity: 10 mg in 1 1
Code: G162GK9U4W
Classification: ACTIB
Leflunomide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62135-794
Application NumberANDA077086
Product Classification
M
Marketing Category
C73584
G
Generic Name
Leflunomide
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2023
FDA Product Classification
INGREDIENTS (7)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
LEFLUNOMIDEActive
Quantity: 20 mg in 1 1
Code: G162GK9U4W
Classification: ACTIB