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Details for New Drug Application (NDA): 050573

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NDA 050573 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: 050573

Therapeutic Class:Immunological Agents
Ophthalmic Agents

Suppliers and Packaging for NDA: 050573

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INJECTABLE;INJECTION 050573 NDA Novartis Pharmaceuticals Corporation 0078-0109 0078-0109-01 10 AMPULE in 1 BOX (0078-0109-01) > 5 mL in 1 AMPULE (0078-0109-61)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/ML
Approval Date:Nov 14, 1983TE:APRLD:Yes

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