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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51525-0442
Application NumberNDA020189
Product Classification
M
Marketing Category
C73605
G
Generic Name
felbamate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 21, 2018
FDA Product Classification
INGREDIENTS (1)
FELBAMATEActive
Quantity: 600 mg in 5 mL
Code: X72RBB02N8
Classification: ACTIB
felbamate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51525-0430
Application NumberNDA020189
Product Classification
M
Marketing Category
C73605
G
Generic Name
felbamate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 21, 2018
FDA Product Classification
INGREDIENTS (1)
FELBAMATEActive
Quantity: 400 mg in 1 1
Code: X72RBB02N8
Classification: ACTIB
felbamate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51525-0431
Application NumberNDA020189
Product Classification
M
Marketing Category
C73605
G
Generic Name
felbamate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 21, 2018
FDA Product Classification
INGREDIENTS (1)
FELBAMATEActive
Quantity: 600 mg in 1 1
Code: X72RBB02N8
Classification: ACTIB