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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 203880

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NDA 203880 describes CYCLOSPORINE, which is a drug marketed by Apotex, Dr Reddys Labs Sa, Ivax Sub Teva Pharms, Sandoz, Strides Pharma, Deva Holding As, Mylan, Saptalis Pharms, Teva Pharms Usa Inc, Hikma, Padagis Us, Abbvie, Pharm Assoc, and Pharmobedient Cnsltg, and is included in eighteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the cyclosporine profile page.

Summary for 203880

Tradename:	CYCLOSPORINE
Applicant:	Teva Pharms Usa Inc
Ingredient:	cyclosporine
Patents:	0

Medical Subject Heading (MeSH) Categories for 203880

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:	Dec 14, 2023	TE:		RLD:	No

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