Details for New Drug Application (NDA): 219049
NDA 219049 describes CYCLOSPORINE, which is a drug marketed by Apotex, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, Ivax Sub Teva Pharms, Onesource, Qilu, Sandoz, Amneal, Deva Holding As, Jiangsu Anbison, Mylan, Saptalis Pharms, Teva Pharms Usa Inc, Twi Pharms, Hikma, Padagis Us, Abbvie, Pharm Assoc, and Pharmobedient Cnsltg, and is included in twenty-three NDAs. It is available from fourteen suppliers. Additional details are available on the CYCLOSPORINE profile page.
The generic ingredient in CYCLOSPORINE is cyclosporine. There is one drug master file entry for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the cyclosporine profile page.
The generic ingredient in CYCLOSPORINE is cyclosporine. There is one drug master file entry for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the cyclosporine profile page.
Summary for 219049
| Tradename: | CYCLOSPORINE |
| Applicant: | Qilu |
| Ingredient: | cyclosporine |
| Patents: | 0 |
Pharmacology for NDA: 219049
| Mechanism of Action | Calcineurin Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors |
Medical Subject Heading (MeSH) Categories for 219049
Suppliers and Packaging for NDA: 219049
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CYCLOSPORINE | cyclosporine | CAPSULE;ORAL | 219049 | ANDA | Qilu Pharmaceutical Co., Ltd. | 67184-0584 | 67184-0584-1 | 3 BLISTER PACK in 1 CARTON (67184-0584-1) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (67184-0584-0) |
| CYCLOSPORINE | cyclosporine | CAPSULE;ORAL | 219049 | ANDA | Qilu Pharmaceutical Co., Ltd. | 67184-0585 | 67184-0585-1 | 5 BLISTER PACK in 1 CARTON (67184-0585-1) / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (67184-0585-0) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
| Approval Date: | Sep 15, 2025 | TE: | AB1 | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
| Approval Date: | Sep 15, 2025 | TE: | AB1 | RLD: | No | ||||
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