Orange Book product · Brand (NDA)
ARAVA
LEFLUNOMIDE
At a glance
Sep 10, 1998
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 10, 1998
28 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
LEFLUNOMIDE
Strength
10MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 020905
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2021LEFLUNOMIDEGeneric (ANDA)
ANDA 213497 · AET PHARMA
- 2021LEFLUNOMIDEGeneric (ANDA)
ANDA 213652 · AUROBINDO PHARMA
- 2020LEFLUNOMIDEGeneric (ANDA)
ANDA 211863 · LUPIN
- 2019LEFLUNOMIDEGeneric (ANDA)
ANDA 212453 · ABHAI LLC
- 2019LEFLUNOMIDEGeneric (ANDA)
ANDA 212308 · ZYDUS LIFESCIENCES
- 2011LEFLUNOMIDEGeneric (ANDA)
ANDA 091369 · ALEMBIC PHARMS LTD
- 2005LEFLUNOMIDEGeneric (ANDA)
ANDA 077090 · APOTEX
- 2005LEFLUNOMIDEGeneric (ANDA)
ANDA 077083 · BARR
- 2005LEFLUNOMIDEGeneric (ANDA)
ANDA 077087 · FOSUN WANBANG
- 2005LEFLUNOMIDEGeneric (ANDA)
ANDA 077086 · HERITAGE
- 2005LEFLUNOMIDEGeneric (ANDA)
ANDA 077085 · SANDOZ
- 2005LEFLUNOMIDEGeneric (ANDA)
ANDA 077084 · TEVA PHARMS
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
