Last Updated: September 24, 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, Apotex, Breckenridge, Eugia Pharma, Hikma, I3 Pharms, Novugen, Ph Health, and Teva Pharms Usa, and is included in nineteen NDAs. It is available from fourteen suppliers. Additional details are available on the EVEROLIMUS profile page.

The generic ingredient in EVEROLIMUS is everolimus. There is one drug master file entry for this compound. Fifteen 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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