MedPath
FDA Product

LONSURF

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

Basic Information

LONSURF

64842-1025

Regulatory Information

64842-1025

NDA207981

C73594

August 8, 2023

USA

These highlights do not include all the information needed to use LONSURF safely and effectively. See full prescribing information for LONSURF. LONSURF (trifluridine and tipiracil) tablets, for oral use Initial U.S. Approval: 2015

HUMAN PRESCRIPTION DRUG LABEL

13

Company Information

690548730

Active Ingredients

TRIFLURIDINE

Quantity: 15 mg in 1 1

Code: RMW9V5RW38

Class Code: ACTIB

TIPIRACIL HYDROCHLORIDE

Quantity: 6.14 mg in 1 1

Code: 4H59KLQ0A4

Class Code: ACTIM

LACTOSE MONOHYDRATE

Quantity: 90.735 mg in 1 1

Code: EWQ57Q8I5X

Class Code: IACT

STEARIC ACID

Quantity: 1.200 mg in 1 1

Code: 4ELV7Z65AP

Class Code: IACT

STARCH, CORN

Quantity: 6.000 mg in 1 1

Code: O8232NY3SJ

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Quantity: 2.100 mg in 1 1

Code: 3NXW29V3WO

Class Code: IACT

ALCOHOL

Code: 3K9958V90M

Class Code: IACT

MAGNESIUM STEARATE

Quantity: 0.003 mg in 1 1

Code: 70097M6I30

Class Code: IACT

TITANIUM DIOXIDE

Quantity: 0.300 mg in 1 1

Code: 15FIX9V2JP

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Quantity: 0.300 mg in 1 1

Code: 3WJQ0SDW1A

Class Code: IACT

BUTYL ALCOHOL

Code: 8PJ61P6TS3

Class Code: IACT

Active Moieties

TRIFLURIDINE

Code: RMW9V5RW38

TIPIRACIL

Code: NGO10K751P

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