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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 211943

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NDA 211943 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 211943

Tradename:	CYCLOSPORINE
Applicant:	Saptalis Pharms
Ingredient:	cyclosporine
Patents:	0

Medical Subject Heading (MeSH) Categories for 211943

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	EMULSION;OPHTHALMIC			Strength	0.05%
Approval Date:	Jul 5, 2024	TE:	AB	RLD:	No

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