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Details for New Drug Application (NDA): 021924

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NDA 021924 describes TIROSINT, which is a drug marketed by Inst Biochimique and Institut Biochimique and is included in two NDAs. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the TIROSINT profile page.

The generic ingredient in TIROSINT is levothyroxine sodium. There are nine drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the levothyroxine sodium profile page.

Summary for NDA: 021924

Tradename:
TIROSINT
Applicant:
Institut Biochimique
Ingredient:
levothyroxine sodium
Patents:2
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Thyroid)
Formulation / Manufacturing:see details

Pharmacology for NDA: 021924

Ingredient-typeThyroxine

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 Akrimax Pharmaceuticals, LLC 24090-491 24090-491-07 1 BLISTER PACK in 1 CARTON (24090-491-07) > 7 CAPSULE in 1 BLISTER PACK
TIROSINT
levothyroxine sodium
CAPSULE;ORAL 021924 NDA Akrimax Pharmaceuticals, LLC 24090-491 24090-491-84 4 BLISTER PACK in 1 CARTON (24090-491-84) > 7 CAPSULE in 1 BLISTER PACK

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.025MG
Approval Date:Oct 13, 2006TE:RLD:No
Patent:7,691,411Patent Expiration:Mar 14, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:7,723,390Patent Expiration:Mar 14, 2024Product Flag?YSubstance Flag?Delist Request?

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.05MG
Approval Date:Oct 13, 2006TE:RLD:No
Patent:7,691,411Patent Expiration:Mar 14, 2024Product Flag?YSubstance Flag?Delist Request?


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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 verifification 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.

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