Orange Book product · Generic (ANDA)
TERIFLUNOMIDE
TERIFLUNOMIDE
At a glance
Mar 13, 2023
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 13, 2023
3 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
TERIFLUNOMIDE
Strength
7MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 209598
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of TERIFLUNOMIDE
- 2012AUBAGIOBrand (NDA)
NDA 202992 · SANOFI AVENTIS US
- 2025TERIFLUNOMIDEGeneric (ANDA)
ANDA 218663 · CONCORD BIOTECH LTD
- 2024TERIFLUNOMIDEGeneric (ANDA)
ANDA 209697 · TORRENT
- 2023TERIFLUNOMIDEGeneric (ANDA)
ANDA 209677 · SOLA PHARMS
- 2023TERIFLUNOMIDEGeneric (ANDA)
ANDA 209555 · NATCO
- 2023TERIFLUNOMIDEGeneric (ANDA)
ANDA 209639 · BIOCON PHARMA
- 2021TERIFLUNOMIDEGeneric (ANDA)
ANDA 209583 · BRECKENRIDGE
- 2020TERIFLUNOMIDEGeneric (ANDA)
ANDA 209702 · SOMERSET THERAPS LLC
- 2019TERIFLUNOMIDEGeneric (ANDA)
ANDA 209623 · MSN
- 2019TERIFLUNOMIDEGeneric (ANDA)
ANDA 209572 · ALEMBIC
- 2019TERIFLUNOMIDEGeneric (ANDA)
ANDA 209690 · ACCORD HLTHCARE
- 2019TERIFLUNOMIDEGeneric (ANDA)
ANDA 209710 · SANDOZ
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.
