BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Johnson and Johnson
Daiichi Sankyo
Cantor Fitzgerald
US Army

Generated: January 23, 2018

DrugPatentWatch Database Preview

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 two 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
Applicant:Strongbridge Us
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 Taro Pharmaceuticals U.S.A., Inc. 51672-4144 51672-4144-1 100 TABLET in 1 BOTTLE (51672-4144-1)
DARANIDE dichlorphenamide TABLET;ORAL 011366 NDA Taro Pharmaceuticals U.S.A., Inc. 51672-4144 51672-4144-6 30 TABLET in 1 BOTTLE (51672-4144-6)

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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:ORPHAN DRUG EXCLUSIVITY

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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Argus Health
Harvard Business School

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