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Last Updated: March 19, 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 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 ten 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 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

Pharmacology for NDA: 211909

Mechanism of Action	Calcineurin Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors

Medical Subject Heading (MeSH) Categories for 211909

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

Suppliers and Packaging for NDA: 211909

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CYCLOSPORINE	cyclosporine	EMULSION;OPHTHALMIC	211909	ANDA	Amneal Pharmaceuticals NY LLC	69238-1023	69238-1023-3	3 POUCH in 1 CARTON (69238-1023-3) / 10 VIAL, SINGLE-USE in 1 POUCH (69238-1023-7) / .4 mL in 1 VIAL, SINGLE-USE

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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