Details for New Drug Application (NDA): 065040
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NDA 065040 describes CYCLOSPORINE, which is a drug marketed by Apotex, Dr Reddys Labs Sa, Ivax Sub Teva Pharms, Sandoz, Strides Pharma, Deva Holding As, Mylan, Saptalis Pharms, Teva Pharms Usa Inc, Hikma, Padagis Us, Abbvie, Pharm Assoc, and Pharmobedient Cnsltg, and is included in eighteen NDAs. It is available from ten suppliers. Additional details are available on the CYCLOSPORINE profile page.
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.
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 |
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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