FDA.reportPublic FDA data

Application 205014

Type
ANDA
Sponsor
MYLAN INSTITUTIONAL

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
67457-299Naloxone Hydrochloridenaloxone hydrochlorideMylan Institutional LLCANDACurrent
67457-299Naloxone Hydrochloridenaloxone hydrochlorideMylan Institutional LLCANDACurrent
67457-299Naloxone Hydrochloridenaloxone hydrochlorideMylan Institutional LLCANDACurrent
67457-987Naloxone Hydrochloridenaloxone hydrochlorideMylan Institutional LLCANDACurrent
67457-987Naloxone Hydrochloridenaloxone hydrochlorideMylan Institutional LLCANDACurrent
67457-987Naloxone Hydrochloridenaloxone hydrochlorideMylan Institutional LLCANDACurrent