Felbamate
Felbamate Oral Suspension USP
Approved
Approval ID
556de35d-3b98-48d3-a670-50e9d93437a4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 17, 2018
Manufacturers
FDA
NORTHSTAR RX LLC
DUNS: 830546433
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 Code16714-775
Application NumberANDA206314
Product Classification
M
Marketing Category
C73584
G
Generic Name
Felbamate
Product Specifications
Route of AdministrationORAL
Effective DateApril 17, 2018
FDA Product Classification
INGREDIENTS (13)
FelbamateActive
Quantity: 600 mg in 5 mL
Code: X72RBB02N8
Classification: ACTIB
citric acid monohydrateInactive
Code: 2968PHW8QP
Classification: IACT
FD&C Yellow No. 6Inactive
Code: H77VEI93A8
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMInactive
Code: K679OBS311
Classification: IACT
FD&C Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT
glycerinInactive
Code: PDC6A3C0OX
Classification: IACT
methylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
propylparabenInactive
Code: Z8IX2SC1OH
Classification: IACT
sorbitolInactive
Code: 506T60A25R
Classification: IACT
sucraloseInactive
Code: 96K6UQ3ZD4
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT