FDA.reportPublic FDA data

Application 208871

Type
ANDA
Sponsor
AKORN

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
17478-041Naloxone HydrochlorideNaloxone HydrochlorideAkorn, Inc.ANDACurrent
17478-041Naloxone HydrochlorideNaloxone HydrochlorideAkorn, Inc.ANDACurrent
17478-041Naloxone HydrochlorideNaloxone HydrochlorideAkorn, Inc.ANDACurrent
17478-041Naloxone HydrochlorideNaloxone HydrochlorideAkornANDACurrent
17478-041Naloxone HydrochlorideNaloxone HydrochlorideAkorn, Inc.ANDACurrent
17478-041Naloxone HydrochlorideNaloxone HydrochlorideAkornANDACurrent
17478-041Naloxone HydrochlorideNaloxone HydrochlorideAkorn, Inc.ANDACurrent
17478-041Naloxone HydrochlorideNaloxone HydrochlorideAkorn, Inc.ANDACurrent
50090-3294Naloxone HydrochlorideNaloxone HydrochlorideA-S Medication SolutionsANDACurrent
50090-3294Naloxone HydrochlorideNaloxone HydrochlorideA-S Medication SolutionsANDACurrent
52584-058NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-058NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEGeneral Injectables and Vaccines, Inc.ANDACurrent
71872-7018Naloxone HydrochlorideNaloxone HydrochlorideMedical Purchasing Solutions, LLCANDACurrent
71872-7018Naloxone HydrochlorideNaloxone HydrochlorideMedical Purchasing Solutions, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
47456ORIG2017-03-03