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Generated: May 25, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205955

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NDA 205955 describes PITAVASTATIN CALCIUM, which is a drug marketed by Aurobindo Pharma Ltd, Orient Pharma Co Ltd, and Sawai Usa, and is included in three NDAs. Additional details are available on the PITAVASTATIN CALCIUM profile page.

The generic ingredient in PITAVASTATIN CALCIUM is pitavastatin calcium. There are fifteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the pitavastatin calcium profile page.
Summary for 205955
Tradename:PITAVASTATIN CALCIUM
Applicant:Sawai Usa
Ingredient:pitavastatin calcium
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1MG BASE
Approval Date:Feb 3, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2MG BASE
Approval Date:Feb 3, 2017TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 4MG BASE
Approval Date:Feb 3, 2017TE:ABRLD:No

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