Details for New Drug Application (NDA): 210721
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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 210721
Tradename: | CYCLOSPORINE |
Applicant: | Apotex |
Ingredient: | cyclosporine |
Patents: | 0 |
Pharmacology for NDA: 210721
Mechanism of Action | Calcineurin Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors |
Medical Subject Heading (MeSH) Categories for 210721
Suppliers and Packaging for NDA: 210721
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CYCLOSPORINE | cyclosporine | CAPSULE;ORAL | 210721 | ANDA | Apotex Corp. | 60505-4630 | 60505-4630-3 | 30 BLISTER PACK in 1 CARTON (60505-4630-3) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK |
CYCLOSPORINE | cyclosporine | CAPSULE;ORAL | 210721 | ANDA | Apotex Corp. | 60505-4631 | 60505-4631-3 | 30 BLISTER PACK in 1 CARTON (60505-4631-3) / 5 CAPSULE, LIQUID FILLED in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
Approval Date: | Jul 10, 2019 | TE: | AB1 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
Approval Date: | Jul 10, 2019 | TE: | AB1 | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
Approval Date: | Jul 10, 2019 | TE: | AB1 | RLD: | No |
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