FDA.reportPublic FDA data

Application 209862

Type
NDA
Sponsor
KALEO INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EVZIO (AUTOINJECTOR)NALOXONE HYDROCHLORIDESOLUTION;INTRAMUSCULAR, SUBCUTANEOUS2MG/0.4ML (2MG/0.4ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51662-1495EVZIO(R) NALOXONE HClEVZIO(R) NALOXONE HClHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1495EVZIO(R) NALOXONE HClEVZIO(R) NALOXONE HClHF Acquisition Co LLC, DBA HealthFirstNDACurrent
60842-051Evzionaloxone hydrochloridekaleo, Inc.NDACurrent
60842-051Evzionaloxone hydrochloridekaleo, Inc.NDACurrent
72853-051Naloxone Hydrochloridenaloxone hydrochlorideIJ Therapeutics, LLCNDA AUTHORIZED GENERICCurrent
72853-051Naloxone Hydrochloridenaloxone hydrochlorideIJ Therapeutics, LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
46135ORIG2016-12-13
45687ORIG2016-10-27
45633ORIG2016-10-20