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Last Updated: July 4, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021924


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NDA 021924 describes TIROSINT, which is a drug marketed by Institut Biochimique and is included in two NDAs. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TIROSINT profile page.

The generic ingredient in TIROSINT is levothyroxine sodium. There are ten drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the levothyroxine sodium profile page.
Summary for 021924
Tradename:TIROSINT
Applicant:Institut Biochimique
Ingredient:levothyroxine sodium
Patents:2
Formulation / Manufacturing:see details
Paragraph IV (Patent) Challenges for 021924
Tradename Dosage Ingredient NDA Submissiondate
TIROSINT CAPSULE;ORAL levothyroxine sodium 021924 2019-08-01
TIROSINT CAPSULE;ORAL levothyroxine sodium 021924 2017-12-29

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.025MG
Approval Date:Oct 13, 2006TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Mar 14, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Mar 14, 2024Product Flag?YSubstance Flag?Delist Request?

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.05MG
Approval Date:Oct 13, 2006TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Mar 14, 2024Product Flag?YSubstance Flag?Delist Request?

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