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Details for New Drug Application (NDA): 022121

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NDA 022121 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: 022121

Tradename:
TIROSINT
Applicant:
Inst Biochimique
Ingredient:
levothyroxine sodium
Patents:1
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Thyroid)
Formulation / Manufacturing:see details

Pharmacology for NDA: 022121

Ingredient-typeThyroxine

Suppliers and Packaging for NDA: 022121

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TIROSINT
levothyroxine sodium
CAPSULE;ORAL 022121 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 022121 NDA Akrimax Pharmaceuticals, LLC 24090-490 24090-490-84 4 BLISTER PACK in 1 CARTON (24090-490-84) > 7 CAPSULE in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.013MG
Approval Date:Aug 1, 2007TE:RLD:No
Patent:7,723,390Patent Expiration:Mar 14, 2024Product Flag?YSubstance Flag?Delist Request?


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