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Last Updated: April 19, 2024

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 three suppliers. There are five 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. Forty-eight 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:	2
Formulation / Manufacturing:	see details

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 AUTHORIZED GENERIC	Lannett Company, Inc.	0527-4951	0527-4951-32	3 BLISTER PACK in 1 CARTON (0527-4951-32) / 10 CAPSULE in 1 BLISTER PACK
TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924	NDA AUTHORIZED GENERIC	Lannett Company, Inc.	0527-4952	0527-4952-32	3 BLISTER PACK in 1 CARTON (0527-4952-32) / 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
Patent:	⤷ Try a Trial	Patent Expiration:	Mar 14, 2024	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Try a Trial	Patent Expiration:	Mar 14, 2024	Product Flag?	Y	Substance Flag?		Delist Request?

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	0.05MG
Approval Date:	Oct 13, 2006	TE:		RLD:	Yes
Patent:	⤷ Try a Trial	Patent Expiration:	Mar 14, 2024	Product Flag?	Y	Substance Flag?		Delist Request?

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	021924-010	Oct 2, 2009	⤷ Try a Trial	⤷ Try a Trial
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-002	Oct 13, 2006	⤷ Try a Trial	⤷ Try a Trial
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-007	Oct 13, 2006	⤷ Try a Trial	⤷ Try a Trial
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-006	Oct 13, 2006	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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