Details for New Drug Application (NDA): 210385
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The generic ingredient in DIMETHYL FUMARATE is dimethyl fumarate. There are seventy-six drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the dimethyl fumarate profile page.
Summary for 210385
Tradename: | DIMETHYL FUMARATE |
Applicant: | Aurobindo Pharma |
Ingredient: | dimethyl fumarate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 210385
Suppliers and Packaging for NDA: 210385
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DIMETHYL FUMARATE | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 210385 | ANDA | Aurobindo Pharma Limited | 59651-083 | 59651-083-14 | 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-083-14) |
DIMETHYL FUMARATE | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 210385 | ANDA | Aurobindo Pharma Limited | 59651-084 | 59651-084-60 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-084-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | 120MG | ||||
Approval Date: | Dec 22, 2022 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | 240MG | ||||
Approval Date: | Dec 22, 2022 | TE: | AB | RLD: | No |
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