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Serving leading biopharmaceutical companies globally:

Fuji
Dow
Accenture
AstraZeneca
Mallinckrodt
UBS
Covington
QuintilesIMS
US Department of Justice
Teva

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

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Thyroid)
Formulation / Manufacturing:see details

Pharmacology for NDA: 205366

Ingredient-typeThyroxine

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
Accenture
Baxter
McKinsey
Federal Trade Commission
Deloitte
Cantor Fitzgerald
Daiichi Sankyo
Johnson and Johnson

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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