Last Updated: September 24, 2026

Details for New Drug Application (NDA): 219288

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NDA 219288 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 219288

Tradename:	CYCLOSPORINE
Applicant:	Jiangsu Anbison
Ingredient:	cyclosporine
Patents:	0

Medical Subject Heading (MeSH) Categories for 219288

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

Suppliers and Packaging for NDA: 219288

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CYCLOSPORINE	cyclosporine	EMULSION;OPHTHALMIC	219288	ANDA	Cipla USA Inc.	69097-292	69097-292-03	2 POUCH in 1 CARTON (69097-292-03) / 30 VIAL, SINGLE-USE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-USE
CYCLOSPORINE	cyclosporine	EMULSION;OPHTHALMIC	219288	ANDA	Cipla USA Inc.	69097-292	69097-292-97	1 POUCH in 1 CARTON (69097-292-97) / 30 VIAL, SINGLE-USE in 1 POUCH / .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:	Jun 1, 2026	TE:	AB	RLD:	No

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