Details for New Drug Application (NDA): 050715

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NDA 050715 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 050715

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

Pharmacology for NDA: 050715

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

Medical Subject Heading (MeSH) Categories for 050715

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

Suppliers and Packaging for NDA: 050715

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NEORAL	cyclosporine	CAPSULE;ORAL	050715	NDA	Novartis Pharmaceuticals Corporation	0078-0246	0078-0246-15	30 BLISTER PACK in 1 CARTON (0078-0246-15) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0078-0246-61)
NEORAL	cyclosporine	CAPSULE;ORAL	050715	NDA	Novartis Pharmaceuticals Corporation	0078-0248	0078-0248-15	30 BLISTER PACK in 1 CARTON (0078-0248-15) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0078-0248-61)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	25MG
Approval Date:	Jul 14, 1995	TE:	AB1	RLD:	Yes

Profile for product number 002

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

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jul 14, 1995	TE:		RLD:	Yes

Expired US Patents for NDA 050715

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	NEORAL	cyclosporine	CAPSULE;ORAL	050715-002	Jul 14, 1995	5,741,512	⤷ Get Started Free
Novartis	NEORAL	cyclosporine	CAPSULE;ORAL	050715-001	Jul 14, 1995	6,258,808	⤷ Get Started Free
Novartis	NEORAL	cyclosporine	CAPSULE;ORAL	050715-003	Jul 14, 1995	5,962,017	⤷ Get Started Free
Novartis	NEORAL	cyclosporine	CAPSULE;ORAL	050715-002	Jul 14, 1995	6,262,022	⤷ Get Started Free
Novartis	NEORAL	cyclosporine	CAPSULE;ORAL	050715-003	Jul 14, 1995	6,262,022	⤷ Get Started Free
Novartis	NEORAL	cyclosporine	CAPSULE;ORAL	050715-002	Jul 14, 1995	5,866,159	⤷ Get Started Free
Novartis	NEORAL	cyclosporine	CAPSULE;ORAL	050715-003	Jul 14, 1995	5,866,159	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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