Details for New Drug Application (NDA): 215935
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NDA 215935 describes TARPEYO, which is a drug marketed by Calliditas and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the TARPEYO profile page.
The generic ingredient in TARPEYO is budesonide. There are twenty-two drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the budesonide profile page.
The generic ingredient in TARPEYO is budesonide. There are twenty-two drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the budesonide profile page.
Summary for 215935
| Tradename: | TARPEYO |
| Applicant: | Calliditas |
| Ingredient: | budesonide |
| Patents: | 2 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 215935
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 215935
Suppliers and Packaging for NDA: 215935
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TARPEYO | budesonide | CAPSULE, DELAYED RELEASE;ORAL | 215935 | NDA | Calliditas Therapeutics AB | 81749-004 | 81749-004-01 | 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (81749-004-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | 4MG | ||||
| Approval Date: | Dec 15, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 15, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Regulatory Exclusivity Expiration: | Dec 15, 2028 | ||||||||
| Regulatory Exclusivity Use: | TO REDUCE PROTEINURIA IN ADULTS WITH PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN) AT RISK OF RAPID DISEASE PROGRESSION, GENERALLY A URINE PROTEIN-TO-CREATININE RATIO (UPCR) > OR = 1.5 G/G | ||||||||
| Regulatory Exclusivity Expiration: | Dec 20, 2030 | ||||||||
| Regulatory Exclusivity Use: | TO REDUCE THE LOSS OF KIDNEY FUNCTION IN ADULTS WITH PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN) WHO ARE AT RISK FOR DISEASE PROGRESSION, EXCLUDING THE USE PROVIDED FOR IN THE INDICATION APPROVED ON DECEMBER 15, 2021 | ||||||||
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