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Serving leading biopharmaceutical companies globally:

US Department of Justice

Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205366

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NDA 205366 describes LEVOTHYROXINE SODIUM, which is a drug marketed by Fera Pharms Llc, Fresenius Kabi Usa, Par Sterile Products, Merck Kgaa, and Mylan, and is included in five NDAs. It is available from ten suppliers. There are three patents protecting this drug and two Paragraph IV challenges. Additional details are available on the LEVOTHYROXINE SODIUM profile page.

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

Summary for 205366

Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Thyroid)
Formulation / Manufacturing:see details

Pharmacology for NDA: 205366


Suppliers and Packaging for NDA: 205366

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVOTHYROXINE SODIUM levothyroxine sodium POWDER;INTRAVENOUS 205366 ANDA Par Pharmaceutical Companies, Inc. 42023-161 42023-161-01 1 VIAL in 1 CARTON (42023-161-01) > 5 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrength200MCG/VIAL
Approval Date:Dec 7, 2015TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Farmers Insurance
Federal Trade Commission
Cantor Fitzgerald
Daiichi Sankyo
Johnson and Johnson

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