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Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201067

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NDA 201067 describes ISRADIPINE, which is a drug marketed by Elite Labs Inc, Watson Labs Teva, and Mylan Pharms Inc, and is included in three NDAs. It is available from five suppliers. Additional details are available on the ISRADIPINE profile page.

The generic ingredient in ISRADIPINE is isradipine. There are seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the isradipine profile page.
Summary for 201067
Tradename:ISRADIPINE
Applicant:Mylan Pharms Inc
Ingredient:isradipine
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 201067

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG
Approval Date:Nov 27, 2015TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Nov 27, 2015TE:RLD:No

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