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Approved Drug Products containing Trifluridine listed in the FDA Orange Book. Original Data : FDA Website

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01 1HIKMA

02 2INTAS PHARMS LTD

03 1MONARCH PHARMS

04 2NATCO

05 1SANDOZ

06 2TAIHO ONCOLOGY

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PharmaCompass

01

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TRIFLURIDINE

Brand Name : TRIFLURIDINE

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : 1%

Approval Date : 2017-07-28

Application Number : 205438

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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02

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TRIFLURIDINE; TIPIRACIL

Brand Name : TRIFLURIDINE; TIPIRACIL

Dosage Form : TABLET;ORAL

Dosage Strength : 15MG/6.14MG

Approval Date :

Application Number : 214036

RX/OTC/DISCN :

RLD :

TE Code :

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TRIFLURIDINE; TIPIRACIL

Brand Name : TRIFLURIDINE; TIPIRACIL

Dosage Form : TABLET;ORAL

Dosage Strength : 20MG/8.19MG

Approval Date :

Application Number : 214036

RX/OTC/DISCN :

RLD :

TE Code :

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TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE

Brand Name : TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 6.14MG BASE;15MG

Approval Date : 2023-06-13

Application Number : 214008

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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05

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TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE

Brand Name : TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 8.19MG BASE;20MG

Approval Date : 2023-06-13

Application Number : 214008

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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TRIFLURIDINE

Brand Name : VIROPTIC

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : 1%

Approval Date : 1982-01-01

Application Number : 18299

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AT

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TRIFLURIDINE

Brand Name : TRIFLURIDINE

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : 1%

Approval Date : 1995-10-06

Application Number : 74311

RX/OTC/DISCN : RX

RLD : No

TE Code : AT

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TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE

Brand Name : LONSURF

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 6.14MG BASE;15MG

Approval Date : 2015-09-22

Application Number : 207981

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE

Brand Name : LONSURF

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 8.19MG BASE;20MG

Approval Date : 2015-09-22

Application Number : 207981

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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