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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 050625

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NDA 050625 describes SANDIMMUNE, which is a drug marketed by Novartis and is included in three NDAs. It is available from one supplier. Additional details are available on the SANDIMMUNE profile page.

The generic ingredient in SANDIMMUNE 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 050625

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

Pharmacology for NDA: 050625

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

Medical Subject Heading (MeSH) Categories for 050625

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

Suppliers and Packaging for NDA: 050625

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SANDIMMUNE	cyclosporine	CAPSULE;ORAL	050625	NDA	Novartis Pharmaceuticals Corporation	0078-0240	0078-0240-15	30 BLISTER PACK in 1 PACKAGE (0078-0240-15) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0078-0240-61)
SANDIMMUNE	cyclosporine	CAPSULE;ORAL	050625	NDA	Novartis Pharmaceuticals Corporation	0078-0241	0078-0241-15	30 BLISTER PACK in 1 PACKAGE (0078-0241-15) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0078-0241-61)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	25MG
Approval Date:	Mar 2, 1990	TE:	AB2	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Mar 2, 1990	TE:	AB2	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	50MG
Approval Date:	Nov 23, 1992	TE:	BX	RLD:	Yes

Expired US Patents for NDA 050625

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	SANDIMMUNE	cyclosporine	CAPSULE;ORAL	050625-001	Mar 2, 1990	⤷ Get Started Free	⤷ Get Started Free
Novartis	SANDIMMUNE	cyclosporine	CAPSULE;ORAL	050625-002	Mar 2, 1990	⤷ Get Started Free	⤷ Get Started Free
Novartis	SANDIMMUNE	cyclosporine	CAPSULE;ORAL	050625-003	Nov 23, 1992	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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