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Last Updated: February 28, 2021

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Details for New Drug Application (NDA): 210130

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NDA 210130 describes EVEROLIMUS, which is a drug marketed by Mylan, Hikma, Par Pharm, and Teva Pharms Usa, and is included in six NDAs. It is available from four suppliers. Additional details are available on the EVEROLIMUS profile page.

The generic ingredient in EVEROLIMUS is everolimus. There are twelve drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the everolimus profile page.
Summary for 210130
Tradename:EVEROLIMUS
Applicant:Mylan
Ingredient:everolimus
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 210130

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, FOR SUSPENSION;ORALStrength2MG
Approval Date:Apr 19, 2019TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, FOR SUSPENSION;ORALStrength3MG
Approval Date:Apr 19, 2019TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, FOR SUSPENSION;ORALStrength5MG
Approval Date:Apr 19, 2019TE:RLD:No

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