Last Updated: September 24, 2026

Details for New Drug Application (NDA): 211909

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NDA 211909 describes CYCLOSPORINE, which is a drug marketed by Apotex, Dr Reddys Labs Sa, Ivax Sub Teva Pharms, Onesource, Qilu, Sandoz, Amneal, Deva Holding As, Jiangsu Anbison, Mylan, Saptalis Pharms, Teva Pharms Usa Inc, Twi Pharms, Hikma, Padagis Us, Abbvie, Pharm Assoc, and Pharmobedient Cnsltg, and is included in twenty-two NDAs. It is available from twelve suppliers. Additional details are available on the CYCLOSPORINE profile page.

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

Summary for 211909

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

Medical Subject Heading (MeSH) Categories for 211909

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	EMULSION;OPHTHALMIC			Strength	0.05%
Approval Date:	Nov 28, 2025	TE:	AB	RLD:	No

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