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Last Updated: July 7, 2020

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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. Ten 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
Formulation / Manufacturing:see details
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:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:Mar 2, 1990TE:AB2RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Mar 2, 1990TE:AB2RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Nov 23, 1992TE:BXRLD:Yes

Expired US Patents for NDA 050625

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

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