Last Updated: June 25, 2026

Details for New Drug Application (NDA): 215116

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NDA 215116 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 seventeen 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 215116

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

Pharmacology for NDA: 215116

Mechanism of Action	Protein Kinase Inhibitors mTOR Inhibitors
Physiological Effect	Decreased Immunologic Activity

Medical Subject Heading (MeSH) Categories for 215116

Anti-Bacterial Agents
Antibiotics, Antineoplastic
Antifungal Agents
Immunosuppressive Agents

Suppliers and Packaging for NDA: 215116

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SIROLIMUS	sirolimus	SOLUTION;ORAL	215116	ANDA	Rising Pharma Holdings, Inc.	16571-806	16571-806-06	1 CARTON in 1 KIT (16571-806-06) / 1 BOTTLE, GLASS in 1 CARTON / 60 mL in 1 BOTTLE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	1MG/ML
Approval Date:	Jul 15, 2025	TE:	AA	RLD:	No

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