Felbamate
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Approved
Approval ID
878c4e30-061a-cb63-f84a-c07691708960
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 23, 2019
Manufacturers
FDA
Alvogen Inc.
DUNS: 008057330
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
felbamate
PRODUCT DETAILS
NDC Product Code47781-630
Application NumberANDA204595
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 29, 2015
Generic Namefelbamate
INGREDIENTS (7)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FELBAMATEActive
Quantity: 600 mg in 1 1
Code: X72RBB02N8
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
felbamate
PRODUCT DETAILS
NDC Product Code47781-627
Application NumberANDA204595
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 29, 2015
Generic Namefelbamate
INGREDIENTS (7)
FELBAMATEActive
Quantity: 400 mg in 1 1
Code: X72RBB02N8
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT