Orange Book product · Generic (ANDA)
DIMETHYL FUMARATE
DIMETHYL FUMARATE
At a glance
Jun 26, 2024
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 26, 2024
2 yr ago
Today
Pharmaceutical detail
Active ingredient
DIMETHYL FUMARATE
Strength
120MG
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
TE code
AB
Application
ANDA 210377
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DIMETHYL FUMARATE
- 2013TECFIDERABrand (NDA)
NDA 204063 · BIOGEN
- 2025DIMETHYL FUMARATEGeneric (ANDA)
ANDA 210390 · TORRENT
- 2022DIMETHYL FUMARATEGeneric (ANDA)
ANDA 210385 · AUROBINDO PHARMA
- 2022DIMETHYL FUMARATEGeneric (ANDA)
ANDA 210414 · PRINSTON INC
- 2021DIMETHYL FUMARATEGeneric (ANDA)
ANDA 210285 · SAWAI USA
- 2021DIMETHYL FUMARATEGeneric (ANDA)
ANDA 210436 · SOLA PHARMS
- 2020DIMETHYL FUMARATEGeneric (ANDA)
ANDA 210382 · TWI PHARMS
- 2020DIMETHYL FUMARATEGeneric (ANDA)
ANDA 210309 · GLENMARK PHARMS LTD
- 2020DIMETHYL FUMARATEGeneric (ANDA)
ANDA 210226 · LUPIN
- 2020DIMETHYL FUMARATEGeneric (ANDA)
ANDA 210499 · ACCORD HLTHCARE
- 2020DIMETHYL FUMARATEGeneric (ANDA)
ANDA 210440 · ALKEM LABS LTD
- 2020DIMETHYL FUMARATEGeneric (ANDA)
ANDA 210402 · AMNEAL
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.
