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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 215016

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NDA 215016 describes SIROLIMUS, which is a drug marketed by Amneal, Apotex, Hetero Labs Ltd V, MSN, Novitium Pharma, Rising, Torrent, Alkem Labs Ltd, Dr Reddys, Glenmark Pharms Ltd, and Zydus Pharms, and is included in eleven NDAs. It is available from sixteen suppliers. Additional details are available on the SIROLIMUS profile page.

The generic ingredient in SIROLIMUS is sirolimus. There are twenty-one drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the sirolimus profile page.

Summary for 215016

Tradename:	SIROLIMUS
Applicant:	Torrent
Ingredient:	sirolimus
Patents:	0

Medical Subject Heading (MeSH) Categories for 215016

Anti-Bacterial Agents
Antibiotics, Antineoplastic
Antifungal Agents
Immunosuppressive Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	1MG/ML
Approval Date:	Dec 27, 2021	TE:		RLD:	No

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