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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson

Generated: March 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206163

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NDA 206163 describes LEVOTHYROXINE SODIUM, which is a drug marketed by Fresenius Kabi Usa, Par Sterile Products, Piramal Critical, 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 206163
Applicant:Piramal Critical
Ingredient:levothyroxine sodium
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Thyroid)
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrength100MCG/VIAL
Approval Date:Jun 29, 2016TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrength500MCG/VIAL
Approval Date:Jun 29, 2016TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
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Cantor Fitzgerald

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