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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 216728

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NDA 216728 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. Nineteen suppliers are listed for this compound. Additional details are available on the sirolimus profile page.

Summary for 216728

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

Pharmacology for NDA: 216728

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

Medical Subject Heading (MeSH) Categories for 216728

Anti-Bacterial Agents
Antibiotics, Antineoplastic
Antifungal Agents
Immunosuppressive Agents

Suppliers and Packaging for NDA: 216728

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SIROLIMUS	sirolimus	SOLUTION;ORAL	216728	ANDA	Novadoz Pharmaceuticals LLC	72205-099	72205-099-78	1 BOTTLE, GLASS in 1 CARTON (72205-099-78) / 60 mL in 1 BOTTLE, GLASS
SIROLIMUS	sirolimus	SOLUTION;ORAL	216728	ANDA	Northstar Rx LLC	72603-409	72603-409-01	1 BOTTLE, GLASS in 1 CARTON (72603-409-01) / 60 mL in 1 BOTTLE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	1MG/ML
Approval Date:	Jan 19, 2023	TE:	AA	RLD:	No

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