Application 218590

Type
NDA
Sponsor
PURDUE PHARMA LP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZURNAI (AUTOINJECTOR)NALMEFENE HYDROCHLORIDESOLUTION;INTRAMUSCULAR, SUBCUTANEOUSEQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML)YesYes

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81374ORIG 2025-02-26
81337ORIG 2025-02-24
79356ORIG 2024-10-15