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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70954-051
Application NumberANDA211333
Product Classification
M
Marketing Category
C73584
G
Generic Name
Felbamate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 13, 2022
FDA Product Classification
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