Details for New Drug Application (NDA): 213716
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NDA 213716 describes LUPKYNIS, which is a drug marketed by Aurinia and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the LUPKYNIS profile page.
The generic ingredient in LUPKYNIS is voclosporin. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the voclosporin profile page.
The generic ingredient in LUPKYNIS is voclosporin. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the voclosporin profile page.
Summary for 213716
| Tradename: | LUPKYNIS |
| Applicant: | Aurinia |
| Ingredient: | voclosporin |
| Patents: | 3 |
Suppliers and Packaging for NDA: 213716
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LUPKYNIS | voclosporin | CAPSULE;ORAL | 213716 | NDA | Aurinia Pharma U.S., Inc. | 75626-001 | 75626-001-02 | 3 PACKET in 1 CARTON (75626-001-02) / 4 BLISTER PACK in 1 PACKET (75626-001-01) / 15 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 7.9MG | ||||
| Approval Date: | Jan 22, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jan 22, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 10,286,036 | Patent Expiration: | Dec 7, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF PATIENTS WITH ACTIVE LUPUS NEPHRITIS | ||||||||
| Patent: | 11,622,991 | Patent Expiration: | Dec 7, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF PATIENTS WITH ACTIVE LUPUS NEPHRITIS | ||||||||
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