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. Fifty-one 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

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:	⤷ Sign Up	Patent Expiration:	Mar 14, 2024	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	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:	⤷ Sign Up	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	021924-004	Oct 13, 2006	⤷ Sign Up	⤷ Sign Up
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-013	Aug 1, 2007	⤷ Sign Up	⤷ Sign Up
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-008	Oct 2, 2009	⤷ Sign Up	⤷ Sign Up
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-002	Oct 13, 2006	⤷ Sign Up	⤷ Sign Up
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-005	Oct 13, 2006	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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