FDA.reportPublic FDA data

Application 086242

Type
ANDA
Sponsor
HERITAGE PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDETABLET;ORAL10MGNoNo
002HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDETABLET;ORAL50MGNoNo
003HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDETABLET;ORAL25MGNoNo
004HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDETABLET;ORAL100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6440Hydralazine HydrochlorideHydralazine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6440Hydralazine HydrochlorideHydralazine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6440Hydralazine HydrochlorideHydralazine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6440Hydralazine HydrochlorideHydralazine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6440Hydralazine HydrochlorideHydralazine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6440Hydralazine HydrochlorideHydralazine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6441Hydralazine HydrochlorideHydralazine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6441Hydralazine HydrochlorideHydralazine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6441Hydralazine HydrochlorideHydralazine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6441Hydralazine HydrochlorideHydralazine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6441Hydralazine HydrochlorideHydralazine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6441Hydralazine HydrochlorideHydralazine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6442Hydralazine HydrochlorideHydralazine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6442Hydralazine HydrochlorideHydralazine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6442Hydralazine HydrochlorideHydralazine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6442Hydralazine HydrochlorideHydralazine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6442Hydralazine HydrochlorideHydralazine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6442Hydralazine HydrochlorideHydralazine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6443Hydralazine HydrochlorideHydralazine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6443Hydralazine HydrochlorideHydralazine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6443Hydralazine HydrochlorideHydralazine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6443Hydralazine HydrochlorideHydralazine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6443Hydralazine HydrochlorideHydralazine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6443Hydralazine HydrochlorideHydralazine HydrochlorideMajor PharmaceuticalsANDACurrent
23155-001HYDRALAZINE HYDROCHLORIDEhydralazine hydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-001HYDRALAZINE HYDROCHLORIDEhydralazine hydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-001Hydralazine HydrochlorideHydralazine HydrochlorideHeritage Pharmaceuticals IncANDACurrent
23155-002HYDRALAZINE HYDROCHLORIDEhydralazine hydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-002HYDRALAZINE HYDROCHLORIDEhydralazine hydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-002Hydralazine HydrochlorideHydralazine HydrochlorideHeritage Pharmaceuticals IncANDACurrent
23155-003HYDRALAZINE HYDROCHLORIDEhydralazine hydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-003HYDRALAZINE HYDROCHLORIDEhydralazine hydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-003Hydralazine HydrochlorideHydralazine HydrochlorideHeritage Pharmaceuticals IncANDACurrent
23155-004HYDRALAZINE HYDROCHLORIDEhydralazine hydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-004HYDRALAZINE HYDROCHLORIDEhydralazine hydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-004Hydralazine HydrochlorideHydralazine HydrochlorideHeritage Pharmaceuticals IncANDACurrent
43063-392Hydralazine HydrochlorideHydralazine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-392Hydralazine HydrochlorideHydralazine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-392HYDRALAZINE HYDROCHLORIDEhydralazine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-392HYDRALAZINE HYDROCHLORIDEhydralazine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-392HYDRALAZINE HYDROCHLORIDEhydralazine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-392HYDRALAZINE HYDROCHLORIDEhydralazine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43353-742Hydralazine HydrochlorideHydralazine HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-756Hydralazine HydrochlorideHydralazine HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-919Hydralazine HydrochlorideHydralazine HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
48433-309Hydralazine HydrochlorideHydralazine HydrochlorideSafecor Health, LLCANDACurrent
50090-3834Hydralazine HydrochlorideHydralazine HydrochlorideA-S Medication SolutionsANDACurrent
50090-3834Hydralazine HydrochlorideHydralazine HydrochlorideA-S Medication SolutionsANDACurrent
50090-3834Hydralazine Hydrochloridehydralazine hydrochlorideA-S Medication SolutionsANDACurrent
50090-4641Hydralazine Hydrochloridehydralazine hydrochlorideA-S Medication SolutionsANDACurrent
50090-4641Hydralazine HydrochlorideHydralazine HydrochlorideA-S Medication SolutionsANDACurrent
50436-4034Hydralazine HydrochlorideHydralazine HydrochlorideUnit Dose ServicesANDACurrent
50436-7376Hydralazine HydrochlorideHydralazine HydrochlorideUnit Dose ServicesANDACurrent
50436-7379Hydralazine HydrochlorideHydralazine HydrochlorideUnit Dose ServicesANDACurrent
51655-305HYDRALAZINE HYDROCHLORIDEhydralazine hydrochlorideNorthwind PharmaceuticalsANDACurrent
51655-305HYDRALAZINE HYDROCHLORIDEhydralazine hydrochlorideNorthwind PharmaceuticalsANDACurrent
51655-916HYDRALAZINE HYDROCHLORIDEhydralazine hydrochlorideNorthwind PharmaceuticalsANDACurrent
51655-916HYDRALAZINE HYDROCHLORIDEhydralazine hydrochlorideNorthwind PharmaceuticalsANDACurrent
53217-019Hydralazine HydrochlorideHydralazine HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
55154-2082Hydralazine HydrochlorideHydralazine HydrochlorideCardinal Health 107, LLCANDACurrent
55154-2082Hydralazine HydrochlorideHydralazine HydrochlorideCardinal HealthANDACurrent
55154-2082Hydralazine HydrochlorideHydralazine HydrochlorideCardinal HealthANDACurrent
55154-2083Hydralazine HydrochlorideHydralazine HydrochlorideCardinal Health 107, LLCANDACurrent
55154-2083Hydralazine HydrochlorideHydralazine HydrochlorideCardinal HealthANDACurrent
55154-2083Hydralazine HydrochlorideHydralazine HydrochlorideCardinal HealthANDACurrent
55154-4179Hydralazine HydrochlorideHydralazine HydrochlorideCardinal HealthANDACurrent
55154-4180Hydralazine HydrochlorideHydralazine HydrochlorideCardinal HealthANDACurrent
55154-6628Hydralazine HydrochlorideHydralazine HydrochlorideCardinal HealthANDACurrent
55154-6628Hydralazine HydrochlorideHydralazine HydrochlorideCardinal HealthANDACurrent
55154-6628Hydralazine HydrochlorideHydralazine HydrochlorideCardinal HealthANDACurrent
55154-6628Hydralazine HydrochlorideHydralazine HydrochlorideCardinal HealthANDACurrent
55154-6628Hydralazine HydrochlorideHydralazine HydrochlorideCardinal HealthANDACurrent
55154-7293Hydralazine HydrochlorideHydralazine HydrochlorideCardinal HealthANDACurrent
55154-7293Hydralazine HydrochlorideHydralazine HydrochlorideCardinal HealthANDACurrent
55154-7293Hydralazine HydrochlorideHydralazine HydrochlorideCardinal HealthANDACurrent
55154-7293Hydralazine HydrochlorideHydralazine HydrochlorideCardinal Health 107, LLCANDACurrent
55154-7293Hydralazine HydrochlorideHydralazine HydrochlorideCardinal HealthANDACurrent
55154-7293Hydralazine HydrochlorideHydralazine HydrochlorideCardinal HealthANDACurrent
55154-7294Hydralazine HydrochlorideHydralazine HydrochlorideCardinal HealthANDACurrent
55154-7294Hydralazine HydrochlorideHydralazine HydrochlorideCardinal HealthANDACurrent