Last Updated: May 24, 2026

Details for New Drug Application (NDA): 050716

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NDA 050716 describes NEORAL, which is a drug marketed by Novartis and is included in two NDAs. It is available from one supplier. Additional details are available on the NEORAL profile page.

The generic ingredient in NEORAL 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 050716

Tradename:	NEORAL
Applicant:	Novartis
Ingredient:	cyclosporine
Patents:	0

Pharmacology for NDA: 050716

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

Medical Subject Heading (MeSH) Categories for 050716

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

Suppliers and Packaging for NDA: 050716

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NEORAL	cyclosporine	SOLUTION;ORAL	050716	NDA	Novartis Pharmaceuticals Corporation	0078-0274	0078-0274-22	1 BOTTLE in 1 CARTON (0078-0274-22) / 50 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	100MG/ML
Approval Date:	Jul 14, 1995	TE:	AB1	RLD:	Yes

Expired US Patents for NDA 050716

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	NEORAL	cyclosporine	SOLUTION;ORAL	050716-001	Jul 14, 1995	5,985,321	⤷ Start Trial
Novartis	NEORAL	cyclosporine	SOLUTION;ORAL	050716-001	Jul 14, 1995	5,866,159	⤷ Start Trial
Novartis	NEORAL	cyclosporine	SOLUTION;ORAL	050716-001	Jul 14, 1995	5,342,625	⤷ Start Trial
Novartis	NEORAL	cyclosporine	SOLUTION;ORAL	050716-001	Jul 14, 1995	5,962,017	⤷ Start Trial
Novartis	NEORAL	cyclosporine	SOLUTION;ORAL	050716-001	Jul 14, 1995	5,962,014	⤷ Start Trial
Novartis	NEORAL	cyclosporine	SOLUTION;ORAL	050716-001	Jul 14, 1995	6,262,022	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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