Last Updated: May 10, 2026

Details for New Drug Application (NDA): 065040

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NDA 065040 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 eleven 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 065040

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

Pharmacology for NDA: 065040

Mechanism of Action	Calcineurin Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors

Medical Subject Heading (MeSH) Categories for 065040

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

Suppliers and Packaging for NDA: 065040

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CYCLOSPORINE	cyclosporine	CAPSULE;ORAL	065040	ANDA	Apotex Corp.	60505-0133	60505-0133-0	30 CAPSULE, GELATIN COATED in 1 BOTTLE (60505-0133-0)
CYCLOSPORINE	cyclosporine	CAPSULE;ORAL	065040	ANDA	Apotex Corp.	60505-0134	60505-0134-0	30 CAPSULE, GELATIN COATED in 1 BOTTLE (60505-0134-0)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	25MG
Approval Date:	May 9, 2002	TE:	AB2	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	May 9, 2002	TE:	AB2	RLD:	No

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