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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 206977


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NDA 206977 describes TIROSINT-SOL, which is a drug marketed by Ibsa and is included in one NDA. It is available from one supplier. There are three patents 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. Fifty-three suppliers are listed for this compound. Additional details are available on the levothyroxine sodium profile page.
Summary for 206977
Tradename:TIROSINT-SOL
Applicant:Ibsa
Ingredient:levothyroxine sodium
Patents:3
Pharmacology for NDA: 206977
Suppliers and Packaging for NDA: 206977
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TIROSINT-SOL levothyroxine sodium SOLUTION;ORAL 206977 NDA IBSA Pharma Inc. 71858-0105 71858-0105-1 2 POUCH in 1 CARTON (71858-0105-1) / 5 AMPULE in 1 POUCH (71858-0105-4) / 1 mL in 1 AMPULE (71858-0105-6)
TIROSINT-SOL levothyroxine sodium SOLUTION;ORAL 206977 NDA IBSA Pharma Inc. 71858-0105 71858-0105-2 6 POUCH in 1 CARTON (71858-0105-2) / 5 AMPULE in 1 POUCH (71858-0105-4) / 1 mL in 1 AMPULE (71858-0105-6)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength13MCG/ML
Approval Date:Dec 15, 2016TE:RLD:Yes
Patent:10,537,538Patent Expiration:Feb 28, 2037Product Flag?YSubstance Flag?Delist Request?
Patent:11,096,913Patent Expiration:Feb 28, 2037Product Flag?YSubstance Flag?Delist Request?
Patent:11,241,382Patent Expiration:Sep 17, 2039Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF HYPOTHYROIDISM BY ORAL ADMINISTRATION OF L-THYROXINE TO A PATIENT ON AN EMPTY STOMACH 15 MINUTES BEFORE BREAKFAST

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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