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Last Updated: April 13, 2024

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.
Summary for 011366
Formulation / Manufacturing:see details
Pharmacology for NDA: 011366
Mechanism of ActionCarbonic 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:DISCNDosage:TABLET;ORALStrength50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Aug 7, 2015TE:ABRLD:Yes

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