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Serving hundreds of leading biopharmaceutical companies globally:

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Generated: May 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076187

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NDA 076187 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 076187
Tradename:LEVOTHYROXINE SODIUM
Applicant:Mylan
Ingredient:levothyroxine sodium
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Thyroid)
Formulation / Manufacturing:see details
Pharmacology for NDA: 076187
Ingredient-typeThyroxine
Suppliers and Packaging for NDA: 076187
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVOTHYROXINE SODIUM levothyroxine sodium TABLET;ORAL 076187 ANDA Mylan Pharmaceuticals Inc. 0378-1800 N 0378-1800-10
LEVOTHYROXINE SODIUM levothyroxine sodium TABLET;ORAL 076187 ANDA Mylan Pharmaceuticals Inc. 0378-1800 N 0378-1800-77

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date:Jun 5, 2002TE:AB1,AB2,AB3,AB4RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date:Jun 5, 2002TE:AB1,AB2,AB3,AB4RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date:Jun 5, 2002TE:AB1,AB2,AB3,AB4RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

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Harvard Business School
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