Orange Book product · Generic (ANDA)
LEFLUNOMIDE
LEFLUNOMIDE
At a glance
May 10, 2021
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 10, 2021
5 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
LEFLUNOMIDE
Strength
10MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 213497
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of LEFLUNOMIDE
- 1998ARAVABrand (NDA)
NDA 020905 · SANOFI AVENTIS US
- 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.
