FDA.reportPublic FDA data

Application 207634

Type
ANDA
Sponsor
SOMERSET THERAPS LLC

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
51662-1426NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1426NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
70069-072Naloxone HydrochlorideNaloxone HydrochlorideSomerset Therapeutics, LLCANDACurrent
70069-072Naloxone HydrochlorideNaloxone HydrochlorideSomerset Therapeutics, LLCANDACurrent
70069-072Naloxone HydrochlorideNaloxone HydrochlorideSomerset Therapeutics, LLCANDACurrent