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Generated: November 17, 2018

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Details for New Drug Application (NDA): 011366

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NDA 011366 describes KEVEYIS, which is a drug marketed by Strongbridge Us 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. Two suppliers are listed for this compound. Additional details are available on the dichlorphenamide profile page.
Summary for 011366
Tradename:KEVEYIS
Applicant:Strongbridge Us
Ingredient:dichlorphenamide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 011366
Ingredient-typeSulfonamides
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 Taro Pharmaceuticals U.S.A., Inc. 51672-4144 51672-4144-0 10 BLISTER PACK in 1 BOX, UNIT-DOSE (51672-4144-0) > 10 TABLET in 1 BLISTER PACK
DARANIDE dichlorphenamide TABLET;ORAL 011366 NDA Taro Pharmaceuticals U.S.A., Inc. 51672-4144 51672-4144-1 100 TABLET in 1 BOTTLE (51672-4144-1)

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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:RLD:Yes
Regulatory Exclusivity Expiration:Aug 7, 2022
Regulatory Exclusivity Use:TREATMENT OF PRIMARY HYPERKALEMIC PERIODIC PARALYSIS, PRIMARY HYPOKALEMIC PERIOD PARALYSIS, AND RELATED VARIANTS

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