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Last Updated: July 25, 2024

Details for New Drug Application (NDA): 210130


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NDA 210130 describes EVEROLIMUS, which is a drug marketed by Mylan, Alkem Labs Ltd, Biocon Pharma, Breckenridge, Endo Operations, Hikma, and Teva Pharms Usa, and is included in eleven NDAs. It is available from nine 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. Ten 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
Suppliers and Packaging for NDA: 210130
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EVEROLIMUS everolimus TABLET, FOR SUSPENSION;ORAL 210130 ANDA Mylan Pharmaceuticals Inc. 0378-0005 0378-0005-85 4 BLISTER PACK in 1 CARTON (0378-0005-85) / 7 TABLET, FOR SUSPENSION in 1 BLISTER PACK
EVEROLIMUS everolimus TABLET, FOR SUSPENSION;ORAL 210130 ANDA Mylan Pharmaceuticals Inc. 0378-0006 0378-0006-85 4 BLISTER PACK in 1 CARTON (0378-0006-85) / 7 TABLET, FOR SUSPENSION in 1 BLISTER PACK

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

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