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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 219955

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NDA 219955 describes EVEROLIMUS, which is a drug marketed by Amneal, Biocon Pharma, Mylan, Natco, Alkem Labs Ltd, Breckenridge, Hikma, Novugen, Ph Health, and Teva Pharms Usa, and is included in sixteen NDAs. It is available from ten 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. Eleven suppliers are listed for this compound. Additional details are available on the everolimus profile page.

Summary for 219955

Tradename:	EVEROLIMUS
Applicant:	Novugen
Ingredient:	everolimus
Patents:	0

Medical Subject Heading (MeSH) Categories for 219955

Antineoplastic Agents
Immunosuppressive Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2.5MG
Approval Date:	Oct 30, 2025	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Oct 30, 2025	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	7.5MG
Approval Date:	Oct 30, 2025	TE:	AB	RLD:	No

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