Details for New Drug Application (NDA): 209811

NDA 209811 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 209811

Tradename:	CYCLOSPORINE
Applicant:	Deva Holding As
Ingredient:	cyclosporine
Patents:	0

Pharmacology for NDA: 209811

Mechanism of Action

Calcineurin Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors

Medical Subject Heading (MeSH) Categories for 209811

Antifungal Agents

Antirheumatic Agents

Calcineurin Inhibitors

Dermatologic Agents

Enzyme Inhibitors

Immunosuppressive Agents

Suppliers and Packaging for NDA: 209811

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CYCLOSPORINE	cyclosporine	EMULSION;OPHTHALMIC	209811	ANDA	Devatis Inc.	73043-005	73043-005-01	3 POUCH in 1 CARTON (73043-005-01) / 10 VIAL, SINGLE-USE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-USE
CYCLOSPORINE	cyclosporine	EMULSION;OPHTHALMIC	209811	ANDA	Devatis Inc.	73043-005	73043-005-02	6 POUCH in 1 CARTON (73043-005-02) / 10 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:	May 21, 2024	TE:	AB	RLD:	No

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