Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 011366

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KEVEYIS (DICHLORPHENAMIDE)
50MG
Marketing Status: Prescription

Active Ingredient: DICHLORPHENAMIDE
Proprietary Name: KEVEYIS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N011366
Product Number: 002
Approval Date: Aug 7, 2015
Applicant Holder Full Name: XERIS PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DARANIDE (DICHLORPHENAMIDE)
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: DICHLORPHENAMIDE
Proprietary Name: DARANIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N011366
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: XERIS PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information