FDA — authorised 27 March 2013
- Application: NDA204063
- Marketing authorisation holder: BIOGEN INC
- Local brand name: TECFIDERA
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
🇺🇸 BG00012 (DMF) in United States
FDA authorised BG00012 (DMF) on 27 March 2013
Marketing authorisations
FDA — authorised 17 August 2020
- Application: ANDA210531
- Marketing authorisation holder: MYLAN
- Local brand name: DIMETHYL FUMARATE
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 24 September 2020
- Application: ANDA210538
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: DIMETHYL FUMARATE
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 24 September 2020
- Application: ANDA210305
- Marketing authorisation holder: CIPLA
- Local brand name: DIMETHYL FUMARATE
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 24 September 2020
- Application: ANDA210402
- Marketing authorisation holder: AMNEAL
- Local brand name: DIMETHYL FUMARATE
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 24 September 2020
- Application: ANDA210440
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: DIMETHYL FUMARATE
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 24 September 2020
- Application: ANDA210460
- Marketing authorisation holder: MSN
- Local brand name: DIMETHYL FUMARATE
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 24 September 2020
- Application: ANDA210499
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: DIMETHYL FUMARATE
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 24 September 2020
- Application: ANDA210500
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: DIMETHYL FUMARATE
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 6 October 2020
- Application: ANDA210309
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: DIMETHYL FUMARATE
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 6 October 2020
- Application: ANDA210226
- Marketing authorisation holder: LUPIN
- Local brand name: DIMETHYL FUMARATE
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 14 October 2020
- Application: ANDA210382
- Marketing authorisation holder: TWI PHARMS
- Local brand name: DIMETHYL FUMARATE
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 26 March 2021
- Application: ANDA210436
- Marketing authorisation holder: SOLA PHARMS
- Local brand name: DIMETHYL FUMARATE
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 21 December 2021
- Application: ANDA210285
- Marketing authorisation holder: SAWAI USA
- Local brand name: DIMETHYL FUMARATE
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 18 October 2022
- Application: ANDA210414
- Marketing authorisation holder: PRINSTON INC
- Local brand name: DIMETHYL FUMARATE
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 22 December 2022
- Application: ANDA210385
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: DIMETHYL FUMARATE
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 26 June 2024
- Application: ANDA210377
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: DIMETHYL FUMARATE
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 6 January 2025
- Application: ANDA210390
- Marketing authorisation holder: TORRENT
- Local brand name: DIMETHYL FUMARATE
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA210291
- Marketing authorisation holder: SHILPA MEDICARE LTD
- Local brand name: DIMETHYL FUMARATE
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
Frequently asked questions
Is BG00012 (DMF) approved in United States?
Yes. FDA authorised it on 27 March 2013; FDA authorised it on 17 August 2020; FDA authorised it on 24 September 2020.
Who is the marketing authorisation holder for BG00012 (DMF) in United States?
BIOGEN INC holds the US marketing authorisation.