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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 210414


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NDA 210414 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, Macleods Pharms Ltd, MSN, Mylan, Prinston Inc, Sawai Usa, Sola Pharms, Twi Pharms, and Zydus Pharms, and is included in sixteen NDAs. It is available from nineteen 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 210414
Tradename:DIMETHYL FUMARATE
Applicant:Prinston Inc
Ingredient:dimethyl fumarate
Patents:0
Medical Subject Heading (MeSH) Categories for 210414
Suppliers and Packaging for NDA: 210414
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIMETHYL FUMARATE dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 210414 ANDA Solco Healthcare US, LLC 43547-024 43547-024-14 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43547-024-14)
DIMETHYL FUMARATE dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 210414 ANDA Solco Healthcare US, LLC 43547-025 43547-025-06 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43547-025-06)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrength120MG
Approval Date:Oct 18, 2022TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrength240MG
Approval Date:Oct 18, 2022TE:ABRLD:No

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