FDA.reportPublic FDA data

Application 213279

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEINJECTABLE;INJECTION1MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51662-1586NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
55150-345Naloxone HydrochlorideNaloxone HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-345Naloxone HydrochlorideNaloxone HydrochlorideAuroMedics Pharma LLCANDACurrent