Felbatol
FELBATOL® (felbamate) Tablets 400 mg and 600 mg, Oral Suspension 600 mg/5 mL IN-00431-19/140907-0218 Rev. 2/2018 SOV-IN-00431-19/500489-02 Rev. 2/2018
Approved
Approval ID
2f522701-397a-11de-8a39-0800200c9a66
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 14, 2011
Manufacturers
FDA
Meda Pharmaceuticals Inc.
DUNS: 051229602
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 Code0037-0430
Application NumberNDA020189
Product Classification
M
Marketing Category
C73594
G
Generic Name
felbamate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 14, 2011
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 Code0037-0442
Application NumberNDA020189
Product Classification
M
Marketing Category
C73594
G
Generic Name
felbamate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 14, 2011
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
FELBAMATEActive
Quantity: 600 mg in 5 mL
Code: X72RBB02N8
Classification: ACTIB
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
felbamate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0037-0431
Application NumberNDA020189
Product Classification
M
Marketing Category
C73594
G
Generic Name
felbamate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 14, 2011
FDA Product Classification
INGREDIENTS (1)
FELBAMATEActive
Quantity: 600 mg in 1 1
Code: X72RBB02N8
Classification: ACTIB