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Generated: May 21, 2018

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 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 205366
Applicant:Par Sterile Products
Ingredient:levothyroxine sodium
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 E 42023-161-01

Profile for product number 001

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

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