Details for New Drug Application (NDA): 021924

✉ Email this page to a colleague

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:	7,691,411	Patent Expiration:	Mar 14, 2024	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	7,723,390	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:	7,691,411	Patent Expiration:	Mar 14, 2024	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 021924

Subscribe to access the full database, or Subscribe
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-012	Apr 25, 2017	7,691,411	⤷ Subscribe
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-012	Apr 25, 2017	7,723,390	⤷ Subscribe
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-003	Oct 13, 2006	7,723,390	⤷ Subscribe
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-010	Oct 2, 2009	7,691,411	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.