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Cantor Fitzgerald
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Generated: May 27, 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 eleven 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-three suppliers are listed for this compound. Additional details are available on the levothyroxine sodium profile page.
Summary for 206163
Tradename:LEVOTHYROXINE SODIUM
Applicant:Piramal Critical
Ingredient:levothyroxine sodium
Patents:0
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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Covington
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