Details for New Drug Application (NDA): 215935
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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 |
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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