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Generated: December 16, 2017

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 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 076187

Tradename:1
Applicant:1
Ingredient:1
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 0378-1800-77 90 TABLET in 1 BOTTLE, PLASTIC (0378-1800-77)
LEVOTHYROXINE SODIUM levothyroxine sodium TABLET;ORAL 076187 ANDA Mylan Pharmaceuticals Inc. 0378-1800 0378-1800-10 1000 TABLET in 1 BOTTLE, PLASTIC (0378-1800-10)

Summary 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

Summary 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

Summary 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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