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Last Updated: April 2, 2026

Details for New Drug Application (NDA): 219049

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NDA 219049 describes CYCLOSPORINE, which is a drug marketed by Apotex, Dr Reddys Labs Sa, Ivax Sub Teva Pharms, Onesource Specialty, Qilu, Sandoz, Amneal, Deva Holding As, Mylan, Saptalis Pharms, Teva Pharms Usa Inc, Twi Pharms, Hikma, Padagis Us, Abbvie, Pharm Assoc, and Pharmobedient Cnsltg, and is included in twenty-one NDAs. It is available from eleven suppliers. Additional details are available on the CYCLOSPORINE profile page.

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

Summary for 219049

Tradename:	CYCLOSPORINE
Applicant:	Qilu
Ingredient:	cyclosporine
Patents:	0

Medical Subject Heading (MeSH) Categories for 219049

Antifungal Agents
Antirheumatic Agents
Calcineurin Inhibitors
Dermatologic Agents
Enzyme Inhibitors
Immunosuppressive Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	25MG
Approval Date:	Sep 15, 2025	TE:	AB1	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Sep 15, 2025	TE:	AB1	RLD:	No

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