FDA.reportPublic FDA data

Application 040901

Type
ANDA
Sponsor
HETERO LABS LTD III

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-7973Hydralazine HydrochlorideHydralazine HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7973Hydralazine HydrochlorideHydralazine HydrochlorideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
21695-679HYDRALAZINE HYDROCHLORIDEHydralazine HydrochlorideRebel Distributors CorpANDACurrent
21695-680HYDRALAZINE HYDROCHLORIDEHydralazine HydrochlorideRebel Distributors CorpANDACurrent
21695-694HYDRALAZINE HYDROCHLORIDEHydralazine HydrochlorideRebel Distributors CorpANDACurrent
21695-695HYDRALAZINE HYDROCHLORIDEHydralazine HydrochlorideRebel Distributors CorpANDACurrent
31722-519Hydralazine HydrochlorideHydralazine HydrochlorideCamber PharmaceuticalsANDACurrent
31722-519Hydralazine HydrochlorideHydralazine HydrochlorideCamber Pharmaceuticals, Inc.ANDACurrent
31722-519Hydralazine HydrochlorideHydralazine HydrochlorideCamber Pharmaceuticals, Inc.ANDACurrent
31722-520Hydralazine HydrochlorideHydralazine HydrochlorideCamber PharmaceuticalsANDACurrent
31722-520Hydralazine HydrochlorideHydralazine HydrochlorideCamber Pharmaceuticals, Inc.ANDACurrent
31722-520Hydralazine HydrochlorideHydralazine HydrochlorideCamber Pharmaceuticals, Inc.ANDACurrent
31722-521Hydralazine HydrochlorideHydralazine HydrochlorideCamber Pharmaceuticals, Inc.ANDACurrent
31722-521Hydralazine HydrochlorideHydralazine HydrochlorideCamber Pharmaceuticals, Inc.ANDACurrent
31722-521Hydralazine HydrochlorideHydralazine HydrochlorideCamber PharmaceuticalsANDACurrent
31722-522Hydralazine HydrochlorideHydralazine HydrochlorideCamber PharmaceuticalsANDACurrent
31722-522Hydralazine HydrochlorideHydralazine HydrochlorideCamber Pharmaceuticals, Inc.ANDACurrent
31722-522Hydralazine HydrochlorideHydralazine HydrochlorideCamber Pharmaceuticals, Inc.ANDACurrent
35356-943Hydralazine HydrochlorideHydralazine HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-0137Hydralazine HydrochlorideHydralazine HydrochlorideA-S Medication SolutionsANDACurrent
50090-0137Hydralazine HydrochlorideHydralazine HydrochlorideA-S Medication SolutionsANDACurrent
50090-0137Hydralazine HydrochlorideHydralazine HydrochlorideA-S Medication SolutionsANDACurrent
50090-0137Hydralazine HydrochlorideHydralazine HydrochlorideA-S Medication SolutionsANDACurrent
50090-0139Hydralazine HydrochlorideHydralazine HydrochlorideA-S Medication SolutionsANDACurrent
50090-0139Hydralazine HydrochlorideHydralazine HydrochlorideA-S Medication SolutionsANDACurrent
50090-0139Hydralazine HydrochlorideHydralazine HydrochlorideA-S Medication SolutionsANDACurrent
50090-0139Hydralazine HydrochlorideHydralazine HydrochlorideA-S Medication SolutionsANDACurrent
50090-0139Hydralazine HydrochlorideHydralazine HydrochlorideA-S Medication SolutionsANDACurrent
50090-0139Hydralazine HydrochlorideHydralazine HydrochlorideA-S Medication SolutionsANDACurrent
50090-0139Hydralazine HydrochlorideHydralazine HydrochlorideA-S Medication SolutionsANDACurrent
53808-1062Hydralazine HydrochlorideHydralazine HydrochlorideState of Florida DOH Central PharmacyANDACurrent
63629-5246Hydralazine HydrochlorideHydralazine HydrochlorideBryant Ranch PrepackANDACurrent
63629-5424Hydralazine HydrochlorideHydralazine HydrochlorideBryant Ranch PrepackANDACurrent
68071-1940Hydralazine HydrochlorideHydralazine HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1940Hydralazine HydrochlorideHydralazine HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1940Hydralazine HydrochlorideHydralazine HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-2012Hydralazine HydrochlorideHydralazine HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-2055Hydralazine HydrochlorideHydralazine HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-2055Hydralazine HydrochlorideHydralazine HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-2530Hydralazine HydrochlorideHydralazine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2530Hydralazine HydrochlorideHydralazine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5285Hydralazine HydrochlorideHydralazine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5285Hydralazine HydrochlorideHydralazine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-8087Hydralazine HydrochlorideHydralazine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-8087Hydralazine HydrochlorideHydralazine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
70518-2551Hydralazine HydrochlorideHydralazine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2551Hydralazine HydrochlorideHydralazine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2551Hydralazine HydrochlorideHydralazine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2551Hydralazine HydrochlorideHydralazine HydrochlorideREMEDYREPACK INC.ANDACurrent
70934-764Hydralazine HydrochlorideHydralazine HydrochlorideDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71205-091Hydralazine HydrochlorideHydralazine HydrochlorideProficient Rx LPANDACurrent
71205-091Hydralazine HydrochlorideHydralazine HydrochlorideProficient Rx LPANDACurrent
71335-0202Hydralazine HydrochlorideHydralazine HydrochlorideBryant Ranch PrepackANDACurrent
71335-0202Hydralazine HydrochlorideHydralazine HydrochlorideBryant Ranch PrepackANDACurrent
71335-0202Hydralazine HydrochlorideHydralazine HydrochlorideBryant Ranch PrepackANDACurrent
71335-1589Hydralazine HydrochlorideHydralazine HydrochlorideBryant Ranch PrepackANDACurrent
71335-1685Hydralazine HydrochlorideHydralazine HydrochlorideBryant Ranch PrepackANDACurrent