Details for New Drug Application (NDA): 050574
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NDA 050574 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.
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 050574
| Tradename: | SANDIMMUNE |
| Applicant: | Novartis |
| Ingredient: | cyclosporine |
| Patents: | 0 |
Pharmacology for NDA: 050574
| Mechanism of Action | Calcineurin Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors |
Medical Subject Heading (MeSH) Categories for 050574
Suppliers and Packaging for NDA: 050574
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SANDIMMUNE | cyclosporine | SOLUTION;ORAL | 050574 | NDA | Novartis Pharmaceuticals Corporation | 0078-0110 | 0078-0110-22 | 50 mL in 1 BOTTLE (0078-0110-22) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 100MG/ML | ||||
| Approval Date: | Nov 14, 1983 | TE: | RLD: | Yes | |||||
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