FDA.reportPublic FDA data

Application 204314

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACYCLOVIRACYCLOVIRTABLET;ORAL400MGNoNo
002ACYCLOVIRACYCLOVIRTABLET;ORAL800MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-3250acycloviracyclovirA-S Medication SolutionsANDACurrent
50090-3250acycloviracyclovirA-S Medication SolutionsANDACurrent
50090-3250acycloviracyclovirA-S Medication SolutionsANDACurrent
50090-3254acycloviracyclovirA-S Medication SolutionsANDACurrent
50090-3254acycloviracyclovirA-S Medication SolutionsANDACurrent
50090-3795acycloviracyclovirA-S Medication SolutionsANDACurrent
50090-3795acycloviracyclovirA-S Medication SolutionsANDACurrent
50090-3795acycloviracyclovirA-S Medication SolutionsANDACurrent
50436-0792acycloviracyclovirUnit Dose ServicesANDACurrent
53217-188acycloviracyclovirAidarex Pharmaceuticals LLCANDACurrent
55700-663acycloviracyclovirLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-663acycloviracyclovirLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-663acycloviracyclovirLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-664acycloviracyclovirLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-664acycloviracyclovirLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-664acycloviracyclovirLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-664acycloviracyclovirLake Erie Medical DBA Quality Care Products LLCANDACurrent
58118-0791acycloviracyclovirClinical Solutions Wholesale, LLCANDACurrent
58118-0791acycloviracyclovirClinical Solutions Wholesale, LLCANDACurrent
58118-0791acycloviracyclovirClinical Solutions Wholesale, LLCANDACurrent
63187-366acycloviracyclovirProficient Rx LPANDACurrent
63187-366acycloviracyclovirProficient Rx LPANDACurrent
63629-7613acycloviracyclovirBryant Ranch PrepackANDACurrent
63629-7613acycloviracyclovirBryant Ranch PrepackANDACurrent
63629-7613acycloviracyclovirBryant Ranch PrepackANDACurrent
63629-7613acycloviracyclovirBryant Ranch PrepackANDACurrent
63629-7975acycloviracyclovirBryant Ranch PrepackANDACurrent
63629-7975acycloviracyclovirBryant Ranch PrepackANDACurrent
63629-7975acycloviracyclovirBryant Ranch PrepackANDACurrent
65841-802acycloviracyclovirZydus Lifesciences LimitedANDACurrent
65841-802acycloviracyclovirCadila Healthcare LimitedANDACurrent
65841-802acycloviracyclovirCadila Healthcare LimitedANDACurrent
65841-803acycloviracyclovirZydus Lifesciences LimitedANDACurrent
65841-803acycloviracyclovirCadila Healthcare LimitedANDACurrent
65841-803acycloviracyclovirCadila Healthcare LimitedANDACurrent
66267-007acycloviracyclovirNuCare Pharmaceuticals,Inc.ANDACurrent
66267-007acycloviracyclovirNuCare Pharmaceuticals,Inc.ANDACurrent
66267-399acycloviracyclovirNuCare Pharmaceuticals, IANDACurrent
66267-399acycloviracyclovirNuCare Pharmaceuticals, Inc.ANDACurrent
66267-399acycloviracyclovirNuCare Pharmaceuticals, Inc.ANDACurrent
67296-1185acycloviracyclovirRedPharm Drug, Inc.ANDACurrent
67296-1185acycloviracyclovirRedPharm Drug, Inc.ANDACurrent
67296-1185acycloviracyclovirRedPharm Drug, Inc.ANDACurrent
67296-1185acycloviracyclovirRedPharm Drug, Inc.ANDACurrent
67296-1193acycloviracyclovirRedPharm Drug, Inc.ANDACurrent
67296-1193acycloviracyclovirRedPharm Drug, Inc.ANDACurrent
67296-1193acycloviracyclovirRedPharm Drug, Inc.ANDACurrent
68071-4559acycloviracyclovirNuCare Pharmaceuticals,Inc.ANDACurrent
68382-791acycloviracyclovirZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-791acycloviracyclovirZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-791acycloviracyclovirZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-792acycloviracyclovirZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-792acycloviracyclovirZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-792acycloviracyclovirZydus Pharmaceuticals (USA) Inc.ANDACurrent
68788-7378acycloviracyclovirPreferred Pharmaceuticals Inc.ANDACurrent
68788-7378acycloviracyclovirPreferred Pharmaceuticals Inc.ANDACurrent
68788-7378acycloviracyclovirPreferred Pharmaceuticals Inc.ANDACurrent
68788-7378acycloviracyclovirPreferred Pharmaceuticals Inc.ANDACurrent
68788-7382acycloviracyclovirPreferred Pharmaceuticals Inc.ANDACurrent
68788-7382acycloviracyclovirPreferred Pharmaceuticals Inc.ANDACurrent
68788-7382acycloviracyclovirPreferred Pharmaceuticals Inc.ANDACurrent
68788-7382acycloviracyclovirPreferred Pharmaceuticals Inc.ANDACurrent
69677-104AcyclovirAcyclovirMAS MANAGEMENT GROUP, INC.ANDACurrent
69677-105AcyclovirAcyclovirMAS MANAGEMENT GROUP, INC.ANDACurrent
70518-0018acycloviracyclovirREMEDYREPACK INC.ANDACurrent
70518-1332acycloviracyclovirREMEDYREPACK INC.ANDACurrent
70518-1332acycloviracyclovirREMEDYREPACK INC.ANDACurrent
70518-1332acycloviracyclovirREMEDYREPACK INC.ANDACurrent
70518-1332acycloviracyclovirREMEDYREPACK INC.ANDACurrent
70518-1332acycloviracyclovirREMEDYREPACK INC.ANDACurrent
70518-1363acycloviracyclovirREMEDYREPACK INC.ANDACurrent
70518-1363acycloviracyclovirREMEDYREPACK INC.ANDACurrent
70518-1614acycloviracyclovirREMEDYREPACK INC.ANDACurrent
70518-1614acycloviracyclovirREMEDYREPACK INC.ANDACurrent
70934-131acycloviracyclovirDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-131acycloviracyclovirDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-131acycloviracyclovirDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-131acycloviracyclovirDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-131acycloviracyclovirDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-132acycloviracyclovirDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent