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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 207606

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NDA 207606 describes CYCLOSPORINE, which is a drug marketed by Apotex, Dr Reddys Labs Sa, Ivax Sub Teva Pharms, Onesource Specialty, Qilu, Sandoz, Deva Holding As, Mylan, Saptalis Pharms, Teva Pharms Usa Inc, Hikma, Padagis Us, Abbvie, Pharm Assoc, and Pharmobedient Cnsltg, and is included in nineteen NDAs. It is available from twelve 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 207606

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

Medical Subject Heading (MeSH) Categories for 207606

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	EMULSION;OPHTHALMIC			Strength	0.05%
Approval Date:	Jan 12, 2023	TE:		RLD:	No

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