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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 021924

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NDA 021924 describes TIROSINT, which is a drug marketed by Ibsa and is included in two NDAs. It is available from two suppliers. 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. Fifty-three suppliers are listed for this compound. Additional details are available on the levothyroxine sodium profile page.

Summary for 021924

Tradename:	TIROSINT
Applicant:	Ibsa
Ingredient:	levothyroxine sodium
Patents:	0

Pharmacology for NDA: 021924

Suppliers and Packaging for NDA: 021924

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924	NDA	IBSA Pharma Inc.	71858-0005	71858-0005-1	1 BLISTER PACK in 1 CARTON (71858-0005-1) / 10 CAPSULE in 1 BLISTER PACK
TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924	NDA	IBSA Pharma Inc.	71858-0005	71858-0005-2	3 BLISTER PACK in 1 CARTON (71858-0005-2) / 10 CAPSULE in 1 BLISTER PACK

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	0.025MG
Approval Date:	Oct 13, 2006	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	0.05MG
Approval Date:	Oct 13, 2006	TE:		RLD:	Yes

Profile for product number 004

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	0.075MG
Approval Date:	Oct 13, 2006	TE:		RLD:	Yes

Expired US Patents for NDA 021924

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-012	Apr 25, 2017	⤷ Get Started Free	⤷ Get Started Free
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-010	Oct 2, 2009	⤷ Get Started Free	⤷ Get Started Free
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-009	Oct 2, 2009	⤷ Get Started Free	⤷ Get Started Free
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-011	Apr 25, 2017	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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