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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 065044

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NDA 065044 describes CYCLOSPORINE, which is a drug marketed by Apotex, Dr Reddys Labs Sa, Ivax Sub Teva Pharms, Onesource Specialty, Qilu, Sandoz, Deva Holding As, Mylan, Saptalis Pharms, Teva Pharms Usa Inc, Hikma, Padagis Us, Abbvie, Pharm Assoc, and Pharmobedient Cnsltg, and is included in nineteen NDAs. It is available from twelve 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 065044

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

Pharmacology for NDA: 065044

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

Medical Subject Heading (MeSH) Categories for 065044

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

Suppliers and Packaging for NDA: 065044

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CYCLOSPORINE	cyclosporine	CAPSULE;ORAL	065044	ANDA	Mayne Pharma Inc.	51862-458	51862-458-47	30 BLISTER PACK in 1 BOX (51862-458-47) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (51862-458-01)
CYCLOSPORINE	cyclosporine	CAPSULE;ORAL	065044	ANDA	Mayne Pharma Inc.	51862-460	51862-460-47	30 BLISTER PACK in 1 BOX (51862-460-47) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (51862-460-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Dec 20, 2000	TE:	AB1	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	25MG
Approval Date:	Dec 20, 2000	TE:	AB1	RLD:	No

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