FDA.reportPublic FDA data

Application 204997

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
52584-292NALOXONE HYDROCHLORIDEnaloxone hydrochlorideGeneral Injectables & Vaccines, Inc.ANDACurrent
52584-292NALOXONE HYDROCHLORIDEnaloxone hydrochlorideGeneral Injectables & Vaccines, Inc.ANDACurrent
67457-292Naloxone Hydrochloridenaloxone hydrochlorideMylan Institutional LLCANDACurrent
67457-292Naloxone Hydrochloridenaloxone hydrochlorideMylan Institutional LLCANDACurrent
67457-599Naloxone Hydrochloridenaloxone hydrochlorideMylan Institutional LLCANDACurrent
67457-599Naloxone Hydrochloridenaloxone hydrochlorideMylan Institutional LLCANDACurrent
67457-645Naloxone Hydrochloridenaloxone hydrochlorideMylan Institutional LLCANDACurrent
67457-645Naloxone Hydrochloridenaloxone hydrochlorideMylan Institutional LLCANDACurrent