Felbamate
Felbamate Oral Suspension, USP 600 mg/5 mL
Approved
Approval ID
81c8a2e1-732c-4467-84e9-53fef1655ee2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 13, 2022
Manufacturers
FDA
Novitium Pharma LLC
DUNS: 080301870
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Felbamate
PRODUCT DETAILS
NDC Product Code70954-051
Application NumberANDA211333
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 13, 2022
Generic NameFelbamate
INGREDIENTS (15)
FELBAMATEActive
Quantity: 600 mg in 5 mL
Code: X72RBB02N8
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SACCHARIN SODIUM MONOHYDRATEInactive
Code: A9CO00M9HV
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT