Details for New Drug Application (NDA): 210385
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NDA 210385 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, MSN, Mylan, Prinston Inc, Sawai Usa, Sola Pharms, Torrent, Twi Pharms, and Zydus Pharms, and is included in seventeen 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 is one drug master file entry for this compound. Twenty suppliers are listed for this compound. Additional details are available on the dimethyl fumarate profile page.
The generic ingredient in DIMETHYL FUMARATE is dimethyl fumarate. There is one drug master file entry for this compound. Twenty 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 |
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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