FDA.reportPublic FDA data

Application 212455

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
51662-1544NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1544NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
55150-327Naloxone HydrochlorideNaloxone HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-327Naloxone HydrochlorideNaloxone HydrochlorideAuroMedics Pharma LLCANDACurrent
71872-7219Naloxone HydrochlorideNaloxone HydrochlorideMedical Purchasing Solutions, LLCANDACurrent