Last Updated: September 24, 2026

Details for New Drug Application (NDA): 211212

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NDA 211212 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 is one drug master file entry for this compound. Twenty suppliers are listed for this compound. Additional details are available on the sirolimus profile page.

Summary for 211212

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

Pharmacology for NDA: 211212

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

Medical Subject Heading (MeSH) Categories for 211212

Anti-Bacterial Agents
Antibiotics, Antineoplastic
Antifungal Agents
Immunosuppressive Agents

Suppliers and Packaging for NDA: 211212

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SIROLIMUS	sirolimus	SOLUTION;ORAL	211212	ANDA	Amneal Pharmaceuticals NY LLC	69238-1594	69238-1594-3	1 CARTON in 1 KIT (69238-1594-3) / 1 BOTTLE, GLASS in 1 CARTON (69238-1594-6) / 60 mL in 1 BOTTLE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	1MG/ML
Approval Date:	Oct 18, 2019	TE:	AA	RLD:	No

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