Details for New Drug Application (NDA): 210531
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NDA 210531 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.
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 210531
| Tradename: | DIMETHYL FUMARATE |
| Applicant: | Mylan |
| Ingredient: | dimethyl fumarate |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 210531
Suppliers and Packaging for NDA: 210531
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DIMETHYL FUMARATE | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 210531 | ANDA | Mylan Pharmaceuticals Inc. | 0378-0396 | 0378-0396-14 | 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-0396-14) |
| DIMETHYL FUMARATE | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 210531 | ANDA | Mylan Pharmaceuticals Inc. | 0378-0399 | 0378-0399-91 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-0399-91) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | 120MG | ||||
| Approval Date: | Aug 17, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | 240MG | ||||
| Approval Date: | Aug 17, 2020 | TE: | AB | RLD: | No | ||||
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