Keveyis
These highlights do not include all the information needed to use KEVEYIS safely and effectively. See full prescribing information for KEVEYIS . KEVEYIS (dichlorphenamide) tablets, for oral use Initial U.S. Approval: 1958
Approved
Approval ID
2d4d6a8e-3122-4b91-b46a-5708e60ea5c1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 13, 2021
Manufacturers
FDA
Strongbridge US Inc.
DUNS: 080121041
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dichlorphenamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71090-001
Application NumberNDA011366
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dichlorphenamide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 13, 2021
FDA Product Classification
INGREDIENTS (4)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
DICHLORPHENAMIDEActive
Quantity: 50 mg in 1 1
Code: VVJ6673MHY
Classification: ACTIB