FDA.reportPublic FDA data

Application 212456

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEINJECTABLE;INJECTION0.4MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55150-328NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEAuroMedics Pharma LLCANDACurrent
55150-328NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEAuroMedics Pharma LLCANDACurrent
71872-7215NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEMedical Purchasing Solutions, LLCANDACurrent