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Active ingredient

Dimethyl Fumarate

40 finished FDA listings contain Dimethyl Fumarate as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
DIMETHYL FUMARATE
Dosage forms
Capsule, Capsule, Delayed Release
Routes
Oral
Manufacturers / labelers
20
Strengths listed
120 mg/1 · 240 mg/1
Brand names in FDA listings
Dimethyl Fumarate, Tecfidera

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 1373478

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 204063BIOGEN2013-03-272
ANDA 210440ALKEM LABS LTD2020-09-244
ANDA 210460MSN2020-09-244
ANDA 210500HETERO LABS LTD III2020-09-244
ANDA 210538ZYDUS PHARMS2020-09-244
ANDA 210499ACCORD HLTHCARE2020-09-242
ANDA 210305CIPLA2020-09-242
ANDA 210402AMNEAL2020-09-242
ANDA 210309GLENMARK PHARMS LTD2020-10-062
ANDA 210382TWI PHARMS2020-10-144
ANDA 210436SOLA PHARMS2021-03-262
ANDA 210414PRINSTON INC2022-10-182
ANDA 210385AUROBINDO PHARMA2022-12-224
ANDA 210377MACLEODS PHARMS2024-06-262

Official labeling on DailyMed

Showing the 12 most recent of 20 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.