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Last Updated: November 2, 2024

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.
Summary for 215935
Tradename:TARPEYO
Applicant:Calliditas
Ingredient:budesonide
Patents:2
Pharmacology for NDA: 215935
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:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrength4MG
Approval Date:Dec 15, 2021TE: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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