FDA.reportPublic FDA data

Application 207633

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
0404-9923NALOXONE HYDROCHLORIDEnaloxone hydrochlorideHenry Schein, Inc.ANDACurrent
0404-9923NALOXONE HYDROCHLORIDEnaloxone hydrochlorideHenry Schein, Inc.ANDACurrent
50090-5427Naloxone HydrochlorideNaloxone HydrochlorideA-S Medication SolutionsANDACurrent
52584-120NALOXONE HYDROCHLORIDEnaloxone hydrochlorideGeneral Injectables and Vaccines, INC.ANDACurrent
52584-120NALOXONE HYDROCHLORIDEnaloxone hydrochlorideGeneral Injectables and Vaccines, INC.ANDACurrent
70069-071Naloxone HydrochlorideNaloxone HydrochlorideSomerset Therapeutics, LLCANDACurrent
70069-071Naloxone HydrochlorideNaloxone HydrochlorideSomerset Therapeutics, LLCANDACurrent
70069-071Naloxone HydrochlorideNaloxone HydrochlorideSomerset Therapeutics, LLCANDACurrent
70069-071Naloxone HydrochlorideNaloxone HydrochlorideSomerset Therapeutics, LLCANDACurrent
71872-7198Naloxone HydrochlorideNaloxone HydrochlorideMedical Purchasing Solutions, LLCANDACurrent