Application 213972

Type
NDA
Sponsor
ITERUM THERAP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ORLYNVAHPROBENECID; SULOPENEM ETZADROXILTABLET;ORAL500MG;500MGYesYes

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84664SUPPL 2026-01-06
84598SUPPL 2025-12-31
81729SUPPL 2025-03-25
81726SUPPL 2025-03-25
80535ORIG 2024-12-06
80012ORIG 2024-10-28
79981ORIG 2024-10-25