Last Updated: May 4, 2026

Details for New Drug Application (NDA): 210130

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NDA 210130 describes EVEROLIMUS, which is a drug marketed by Amneal, Biocon Pharma, Mylan, Natco, Alkem Labs Ltd, Breckenridge, Eugia Pharma, Hikma, Novugen, Ph Health, and Teva Pharms Usa, and is included in seventeen NDAs. It is available from twelve 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. Thirteen 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

Medical Subject Heading (MeSH) Categories for 210130

Antineoplastic Agents
Immunosuppressive Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, FOR SUSPENSION;ORAL			Strength	2MG
Approval Date:	Apr 19, 2019	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, FOR SUSPENSION;ORAL			Strength	3MG
Approval Date:	Apr 19, 2019	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, FOR SUSPENSION;ORAL			Strength	5MG
Approval Date:	Apr 19, 2019	TE:		RLD:	No

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