FDA.reportPublic FDA data

Application 212955

Type
ANDA
Sponsor
PURDUE PHARMA LP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NALMEFENE HYDROCHLORIDENALMEFENE HYDROCHLORIDESOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSEQ 2MG BASE/2ML (EQ 1MG BASE/ML)NoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59011-960NALMEFENE HYDROCHLORIDENALMEFENE HYDROCHLORIDEPurdue Pharma L.P.ANDACurrent
59011-960NALMEFENE HYDROCHLORIDENALMEFENE HYDROCHLORIDEPurdue Pharmaceuticals, L.P.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71709ORIG2022-08-04