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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 065054

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NDA 065054 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 065054

Tradename:	CYCLOSPORINE
Applicant:	Dr Reddys Labs Sa
Ingredient:	cyclosporine
Patents:	0

Medical Subject Heading (MeSH) Categories for 065054

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	100MG/ML
Approval Date:	Dec 18, 2001	TE:		RLD:	No

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