Felbamate
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Approved
Approval ID
c0c15d60-1171-11e1-9be0-0002a5d5c51b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 21, 2018
Manufacturers
FDA
Wallace Pharmaceuticals Inc.
DUNS: 962531955
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
felbamate
PRODUCT DETAILS
NDC Product Code51525-0442
Application NumberNDA020189
Marketing CategoryC73605
Route of AdministrationORAL
Effective DateFebruary 21, 2018
Generic Namefelbamate
INGREDIENTS (1)
FELBAMATEActive
Quantity: 600 mg in 5 mL
Code: X72RBB02N8
Classification: ACTIB
felbamate
PRODUCT DETAILS
NDC Product Code51525-0430
Application NumberNDA020189
Marketing CategoryC73605
Route of AdministrationORAL
Effective DateFebruary 21, 2018
Generic Namefelbamate
INGREDIENTS (1)
FELBAMATEActive
Quantity: 400 mg in 1 1
Code: X72RBB02N8
Classification: ACTIB
felbamate
PRODUCT DETAILS
NDC Product Code51525-0431
Application NumberNDA020189
Marketing CategoryC73605
Route of AdministrationORAL
Effective DateFebruary 21, 2018
Generic Namefelbamate
INGREDIENTS (1)
FELBAMATEActive
Quantity: 600 mg in 1 1
Code: X72RBB02N8
Classification: ACTIB