Arava
These highlights do not include all the information needed to use ARAVA safely and effectively. See full prescribing information for ARAVA. ARAVA (leflunomide), tablets, for oral use Initial U.S. Approval: 1998
Approved
Approval ID
320f63f2-fac3-4aee-aff8-85724e00ef52
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 4, 2022
Manufacturers
FDA
sanofi-aventis U.S. LLC
DUNS: 783243835
Products 3
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 Code0088-2161
Application NumberNDA020905
Product Classification
M
Marketing Category
C73594
G
Generic Name
leflunomide
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2022
FDA Product Classification
INGREDIENTS (12)
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LEFLUNOMIDEActive
Quantity: 20 mg in 1 1
Code: G162GK9U4W
Classification: ACTIB
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
leflunomide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0088-2160
Application NumberNDA020905
Product Classification
M
Marketing Category
C73594
G
Generic Name
leflunomide
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2022
FDA Product Classification
INGREDIENTS (11)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
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 Code0088-2162
Application NumberNDA020905
Product Classification
M
Marketing Category
C73594
G
Generic Name
leflunomide
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2022
FDA Product Classification
INGREDIENTS (11)
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
LEFLUNOMIDEActive
Quantity: 100 mg in 1 1
Code: G162GK9U4W
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT