Details for New Drug Application (NDA): 065040
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The generic ingredient in CYCLOSPORINE 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 065040
Tradename: | CYCLOSPORINE |
Applicant: | Apotex |
Ingredient: | cyclosporine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 065040
Mechanism of Action | Calcineurin Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors |
Medical Subject Heading (MeSH) Categories for 065040
Suppliers and Packaging for NDA: 065040
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CYCLOSPORINE | cyclosporine | CAPSULE;ORAL | 065040 | ANDA | Apotex Corp. | 60505-0133 | 60505-0133-0 | 30 CAPSULE, GELATIN COATED in 1 BOTTLE (60505-0133-0) |
CYCLOSPORINE | cyclosporine | CAPSULE;ORAL | 065040 | ANDA | Apotex Corp. | 60505-0134 | 60505-0134-0 | 30 CAPSULE, GELATIN COATED in 1 BOTTLE (60505-0134-0) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
Approval Date: | May 9, 2002 | TE: | AB2 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
Approval Date: | May 9, 2002 | TE: | AB2 | RLD: | No |
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