FDA.reportPublic FDA data

Application 072076

Type
ANDA
Sponsor
INTL MEDICATION

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEINJECTABLE;INJECTION1MG/MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9921NALOXONE HYDROCHLORIDEnaloxone hydrochlorideHenry Schein, Inc.ANDACurrent
0404-9921NALOXONE HYDROCHLORIDEnaloxone hydrochlorideHenry Schein, Inc.ANDACurrent
0404-9922NALOXONE HYDROCHLORIDEnaloxone hydrochlorideHenry Schein, IncANDACurrent
0404-9922NALOXONE HYDROCHLORIDEnaloxone hydrochlorideHenry Schein, IncANDACurrent
0404-9922NALOXONE HYDROCHLORIDEnaloxone hydrochlorideHenry Schein, IncANDACurrent
0404-9922NALOXONE HYDROCHLORIDEnaloxone hydrochlorideHenry Schein, IncANDACurrent
0404-9922NALOXONE HYDROCHLORIDEnaloxone hydrochlorideHenry Schein, IncANDACurrent
0404-9922NALOXONE HYDROCHLORIDEnaloxone hydrochlorideHenry Schein, IncANDACurrent
50090-3154Naloxone HydrochlorideNaloxone HydrochlorideA-S Medication SolutionsANDACurrent
51662-1239NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHF Acquisition Co. LLC, DBA HealthFirstANDACurrent
51662-1239NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHF Acquisition Co. LLC, DBA HealthFirstANDACurrent
51662-1239NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHF Acquisition Co. LLC, DBA HealthFirstANDACurrent
51662-1239NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHF Acquisition Co. LLC, DBA HealthFirstANDACurrent
51662-1239NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHF Acquisition Co. LLC, DBA HealthFirstANDACurrent
52584-369NALOXONE HYDROCHLORIDEnaloxone hydrochlorideGeneral Injectables & Vaccines, Inc.ANDACurrent
52584-369NALOXONE HYDROCHLORIDEnaloxone hydrochlorideGeneral Injectables & Vaccines, Inc.ANDACurrent
52584-369NALOXONE HYDROCHLORIDEnaloxone hydrochlorideGeneral Injectables & Vaccines, Inc.ANDACurrent
52584-369NALOXONE HYDROCHLORIDEnaloxone hydrochlorideGeneral Injectables & Vaccines, Inc.ANDACurrent
52584-369NALOXONE HYDROCHLORIDEnaloxone hydrochlorideGeneral Injectables & Vaccines, Inc.ANDACurrent
52584-469Naloxone HydrochlorideNaloxone HydrochlorideGeneral Injectables & Vaccines, Inc.ANDACurrent
52584-978NALOXONE HYDROCHLORIDEnaloxone hydrochlorideGeneral Injectables & Vaccines, IncANDACurrent
52584-978NALOXONE HYDROCHLORIDEnaloxone hydrochlorideGeneral Injectables & Vaccines, IncANDACurrent
52584-978NALOXONE HYDROCHLORIDEnaloxone hydrochlorideGeneral Injectables & Vaccines, IncANDACurrent
52584-978NALOXONE HYDROCHLORIDEnaloxone hydrochlorideGeneral Injectables & Vaccines, IncANDACurrent
52584-978NALOXONE HYDROCHLORIDEnaloxone hydrochlorideGeneral Injectables & Vaccines, IncANDACurrent
52584-978NALOXONE HYDROCHLORIDEnaloxone hydrochlorideGeneral Injectables & Vaccines, IncANDACurrent
55154-3954Naloxone HydrochlorideNaloxone HydrochlorideCardinal HealthANDACurrent
55154-3954Naloxone HydrochlorideNaloxone HydrochlorideCardinal HealthANDACurrent
70518-2725Naloxone HydrochlorideNaloxone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2725Naloxone HydrochlorideNaloxone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2725Naloxone HydrochlorideNaloxone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2780Naloxone HydrochlorideNaloxone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2780Naloxone HydrochlorideNaloxone HydrochlorideREMEDYREPACK INC.ANDACurrent
71872-7177Naloxone HydrochlorideNaloxone HydrochlorideMedical Purchasing Solutions, LLCANDACurrent
71872-7294Naloxone HydrochlorideNaloxone HydrochlorideMedical Purchasing Solutions, LLCANDACurrent
72336-077LifEMS NALOXONEnaloxone hydrochlorideLifsa Drugs LLCANDACurrent
72336-077LifEMS NALOXONEnaloxone hydrochlorideLifsa Drugs LLCANDACurrent
72336-077LifEMS NALOXONEnaloxone hydrochlorideLifsa Drugs LLCANDACurrent
76329-1469Naloxone HydrochlorideNaloxone HydrochlorideInternational Medication Systems, LimitedANDACurrent
76329-1469Naloxone HydrochlorideNaloxone HydrochlorideInternational Medication Systems, LimitedANDACurrent
76329-1469Naloxone HydrochlorideNaloxone HydrochlorideInternational Medication Systems, LimitedANDACurrent
76329-3369Naloxone HydrochlorideNaloxone HydrochlorideInternational Medication Systems, LimitedANDACurrent
76329-3369Naloxone HydrochlorideNaloxone HydrochlorideInternational Medication Systems, LimitedANDACurrent
76329-3369Naloxone HydrochlorideNaloxone HydrochlorideInternational Medication Systems, LimitedANDACurrent
76329-3469Naloxone HydrochlorideNaloxone HydrochlorideInternational Medication Systems, LimitedANDACurrent
76329-3469Naloxone HydrochlorideNaloxone HydrochlorideInternational Medication Systems, LimitedANDACurrent