Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 207981

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LONSURF (TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE)
EQ 6.14MG BASE;15MG Marketing Status: Prescription

Active Ingredient: TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE
Proprietary Name: LONSURF
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 6.14MG BASE;15MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N207981
Product Number: 001
Approval Date: Sep 22, 2015
Applicant Holder Full Name: TAIHO ONCOLOGY INC
Marketing Status:  Prescription
Patent and Exclusivity Information

LONSURF (TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE)
EQ 8.19MG BASE;20MG Marketing Status: Prescription

Active Ingredient: TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE
Proprietary Name: LONSURF
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 8.19MG BASE;20MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N207981
Product Number: 002
Approval Date: Sep 22, 2015
Applicant Holder Full Name: TAIHO ONCOLOGY INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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