Details for New Drug Application (NDA): 011366
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NDA 011366 describes KEVEYIS, which is a drug marketed by Xeris and is included in one NDA. It is available from two suppliers. Additional details are available on the KEVEYIS profile page.
The generic ingredient in KEVEYIS is dichlorphenamide. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the dichlorphenamide profile page.
The generic ingredient in KEVEYIS is dichlorphenamide. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the dichlorphenamide profile page.
Summary for 011366
| Tradename: | KEVEYIS |
| Applicant: | Xeris |
| Ingredient: | dichlorphenamide |
| Patents: | 0 |
Pharmacology for NDA: 011366
| Mechanism of Action | Carbonic Anhydrase Inhibitors |
Medical Subject Heading (MeSH) Categories for 011366
Suppliers and Packaging for NDA: 011366
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DARANIDE | dichlorphenamide | TABLET;ORAL | 011366 | NDA | Strongbridge US Inc. | 71090-001 | 71090-001-01 | 100 TABLET in 1 BOTTLE (71090-001-01) |
| DARANIDE | dichlorphenamide | TABLET;ORAL | 011366 | NDA | Xeris Pharmaceuticals, Inc. | 72065-001 | 72065-001-01 | 100 TABLET in 1 BOTTLE (72065-001-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Aug 7, 2015 | TE: | AB | RLD: | Yes | ||||
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