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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 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 NDA: 011366

Tradename:
2
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 011366

Ingredient-typeSulfonamides
Mechanism of ActionCarbonic Anhydrase Inhibitors

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)

Summary 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Aug 7, 2015TE:RLD:No
Regulatory Exclusivity Expiration:Aug 7, 2022
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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