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Generated: November 20, 2018

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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 Institut Biochimique and is included in two NDAs. It is available from two suppliers. There are two 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-five suppliers are listed for this compound. Additional details are available on the levothyroxine sodium profile page.
Summary for 021924
Tradename:TIROSINT
Applicant:Institut Biochimique
Ingredient:levothyroxine sodium
Patents:2
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 24090-490 24090-490-07 1 BLISTER PACK in 1 CARTON (24090-490-07) > 7 CAPSULE in 1 BLISTER PACK
TIROSINT levothyroxine sodium CAPSULE;ORAL 021924 NDA Akrimax Pharmaceuticals, LLC 24090-490 24090-490-84 4 BLISTER PACK in 1 CARTON (24090-490-84) > 7 CAPSULE in 1 BLISTER PACK

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.025MG
Approval Date:Oct 13, 2006TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Mar 14, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Mar 14, 2024Product Flag?YSubstance Flag?Delist Request?

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.05MG
Approval Date:Oct 13, 2006TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Mar 14, 2024Product Flag?YSubstance Flag?Delist Request?

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