Basic Information
LONSURF
64842-1020
Regulatory Information
64842-1020
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
LACTOSE MONOHYDRATE
Quantity: 120.980 mg in 1 1
Code: EWQ57Q8I5X
Class Code: IACT
STARCH, CORN
Quantity: 8.000 mg in 1 1
Code: O8232NY3SJ
Class Code: IACT
HYPROMELLOSE, UNSPECIFIED
Quantity: 2.800 mg in 1 1
Code: 3NXW29V3WO
Class Code: IACT
STEARIC ACID
Quantity: 1.600 mg in 1 1
Code: 4ELV7Z65AP
Class Code: IACT
POLYETHYLENE GLYCOL, UNSPECIFIED
Quantity: 0.400 mg in 1 1
Code: 3WJQ0SDW1A
Class Code: IACT
TITANIUM DIOXIDE
Quantity: 0.400 mg in 1 1
Code: 15FIX9V2JP
Class Code: IACT
FERRIC OXIDE RED
Quantity: 0.040 mg in 1 1
Code: 1K09F3G675
Class Code: IACT
ALCOHOL
Code: 3K9958V90M
Class Code: IACT
BUTYL ALCOHOL
Code: 8PJ61P6TS3
Class Code: IACT
MAGNESIUM STEARATE
Quantity: 0.004 mg in 1 1
Code: 70097M6I30
Class Code: IACT
Active Moieties
TIPIRACIL
Code: NGO10K751P
TRIFLURIDINE
Code: RMW9V5RW38