MedPath
FDA Product

TERIFLUNOMIDE

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

Basic Information

TERIFLUNOMIDE

62332-313

Regulatory Information

62332-313

ANDA209572

C73584

February 6, 2023

USA

These highlights do not include all the information needed to use TERIFLUNOMIDE TABLETS safely and effectively. See full prescribing information for TERIFLUNOMIDE TABLETS. TERIFLUNOMIDE tablets, for oral use  INITIAL U.S. APPROVAL: 2012

Human Prescription Drug Label

14

Company Information

079288842

Active Ingredients

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

TERIFLUNOMIDE

Quantity: 7 mg in 1 1

Code: 1C058IKG3B

Class Code: ACTIB

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

HYDROXYPROPYL CELLULOSE (90000 WAMW)

Code: UKE75GEA7F

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

POLYETHYLENE GLYCOL 8000

Code: Q662QK8M3B

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

Active Moieties

TERIFLUNOMIDE

Code: 1C058IKG3B

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