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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 seventeen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the cyclosporine profile page.

Summary for NDA: 050625

Tradename:
SANDIMMUNE
Applicant:
Novartis
Ingredient:
cyclosporine
Patents:0
Therapeutic Class:Immunological Agents
Ophthalmic Agents
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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:Mar 2, 1990TE:AB2RLD:No

Summary for product number 002

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

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Nov 23, 1992TE:BXRLD:No

Expired Orange Book Patents for NDA: 050625

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
SANDIMMUNE
cyclosporine
CAPSULE;ORAL050625-001Mar 2, 19907,511,014► subscribe
Novartis
SANDIMMUNE
cyclosporine
CAPSULE;ORAL050625-002Mar 2, 19907,511,014► subscribe
Novartis
SANDIMMUNE
cyclosporine
CAPSULE;ORAL050625-003Nov 23, 19927,511,014► subscribe
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