Details for New Drug Application (NDA): 050573
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The generic ingredient in SANDIMMUNE is cyclosporine. There are eighteen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the cyclosporine profile page.
Summary for 050573
Tradename: | SANDIMMUNE |
Applicant: | Novartis |
Ingredient: | cyclosporine |
Patents: | 0 |
Pharmacology for NDA: 050573
Mechanism of Action | Calcineurin Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors |
Medical Subject Heading (MeSH) Categories for 050573
Suppliers and Packaging for NDA: 050573
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SANDIMMUNE | cyclosporine | 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) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 50MG/ML | ||||
Approval Date: | Nov 14, 1983 | TE: | AP | RLD: | Yes |
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