MedPath
FDA Product

Felbamate

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Felbamate

16714-775

Regulatory Information

16714-775

ANDA206314

C73584

April 17, 2018

USA

Felbamate Oral Suspension USP

HUMAN PRESCRIPTION DRUG LABEL

1

Company Information

NORTHSTAR RX LLC

830546433

Active Ingredients

Felbamate

Quantity: 600 mg in 5 mL

Code: X72RBB02N8

Class Code: ACTIB

citric acid monohydrate

Code: 2968PHW8QP

Class Code: IACT

FD&C Yellow No. 6

Code: H77VEI93A8

Class Code: IACT

CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM

Code: K679OBS311

Class Code: IACT

FD&C Red No. 40

Code: WZB9127XOA

Class Code: IACT

glycerin

Code: PDC6A3C0OX

Class Code: IACT

methylparaben

Code: A2I8C7HI9T

Class Code: IACT

polysorbate 80

Code: 6OZP39ZG8H

Class Code: IACT

microcrystalline cellulose

Code: OP1R32D61U

Class Code: IACT

propylparaben

Code: Z8IX2SC1OH

Class Code: IACT

sorbitol

Code: 506T60A25R

Class Code: IACT

sucralose

Code: 96K6UQ3ZD4

Class Code: IACT

water

Code: 059QF0KO0R

Class Code: IACT

Active Moieties

Felbamate

Code: X72RBB02N8

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