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Last Updated: July 3, 2020

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Details for New Drug Application (NDA): 206977


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NDA 206977 describes TIROSINT-SOL, which is a drug marketed by Institut Biochimique and is included in one NDA. There is one patent protecting this drug. Additional details are available on the TIROSINT-SOL profile page.

The generic ingredient in TIROSINT-SOL 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 206977
Tradename:TIROSINT-SOL
Applicant:Institut Biochimique
Ingredient:levothyroxine sodium
Patents:1
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength13MCG/ML
Approval Date:Dec 15, 2016TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Feb 28, 2037Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength25MCG/ML
Approval Date:Dec 15, 2016TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Feb 28, 2037Product Flag?YSubstance Flag?Delist Request?

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength50MCG/ML
Approval Date:Dec 15, 2016TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Feb 28, 2037Product Flag?YSubstance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

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