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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 210382


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NDA 210382 describes DIMETHYL FUMARATE, which is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Amneal, Aurobindo Pharma, Cipla, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Lupin, MSN, Mylan, Prinston Inc, Sawai Usa, Sola Pharms, Twi Pharms, and Zydus Pharms, and is included in fifteen NDAs. It is available from eighteen suppliers. Additional details are available on the DIMETHYL FUMARATE profile page.

The generic ingredient in DIMETHYL FUMARATE is dimethyl fumarate. There are seventy-six drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the dimethyl fumarate profile page.
Summary for 210382
Tradename:DIMETHYL FUMARATE
Applicant:Twi Pharms
Ingredient:dimethyl fumarate
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 210382
Suppliers and Packaging for NDA: 210382
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIMETHYL FUMARATE dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 210382 ANDA TWi Pharmaceuticals, Inc. 24979-127 24979-127-02 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (24979-127-02)
DIMETHYL FUMARATE dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 210382 ANDA TWi Pharmaceuticals, Inc. 24979-127 24979-127-21 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (24979-127-21)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrength120MG
Approval Date:Oct 14, 2020TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrength240MG
Approval Date:Oct 14, 2020TE:ABRLD:No

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