Last Updated: November 8, 2026

Details for New Drug Application (NDA): 210050

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NDA 210050 describes EVEROLIMUS, which is a drug marketed by Amneal, Biocon Pharma, Mylan, Natco, Novitium Pharma, Alkem Labs Ltd, Apotex, Breckenridge, Eugia Pharma, Hikma, Neocubes Pharma, Ph Health, Pharmazone, and Teva Pharms Usa, and is included in twenty 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 210050

Tradename:	EVEROLIMUS
Applicant:	Teva Pharms Usa
Ingredient:	everolimus
Patents:	0

Medical Subject Heading (MeSH) Categories for 210050

Antineoplastic Agents
Immunosuppressive Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2.5MG
Approval Date:	Dec 9, 2019	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Dec 9, 2019	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	7.5MG
Approval Date:	Dec 9, 2019	TE:	AB	RLD:	No

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