FDA.reportPublic FDA data

Application 203047

Type
ANDA
Sponsor
HETERO LABS LTD V

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VALACYCLOVIR HYDROCHLORIDEVALACYCLOVIR HYDROCHLORIDETABLET;ORALEQ 500MG BASENoNo
002VALACYCLOVIR HYDROCHLORIDEVALACYCLOVIR HYDROCHLORIDETABLET;ORALEQ 1GM BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
31722-704ValacyclovirValacyclovirCamber Pharmaceuticals, Inc.ANDACurrent
31722-704ValacyclovirValacyclovirCamber Pharmaceuticals, Inc.ANDACurrent
31722-704ValacyclovirValacyclovirCamber Pharmaceuticals, Inc.ANDACurrent
31722-705ValacyclovirValacyclovirCamber Pharmaceuticals, Inc.ANDACurrent
31722-705ValacyclovirValacyclovirCamber Pharmaceuticals, Inc.ANDACurrent
31722-705ValacyclovirValacyclovirCamber Pharmaceuticals, Inc.ANDACurrent
43063-771ValacyclovirValacyclovirPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-771ValacyclovirValacyclovirPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-771ValacyclovirValacyclovirPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-771ValacyclovirValacyclovirPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-771ValacyclovirValacyclovirPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-771ValacyclovirValacyclovirPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-771ValacyclovirValacyclovirPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-771ValacyclovirValacyclovirPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-2510ValacyclovirValacyclovirA-S Medication SolutionsANDACurrent
50090-2510ValacyclovirValacyclovirA-S Medication SolutionsANDACurrent
50090-2510ValacyclovirValacyclovirA-S Medication SolutionsANDACurrent
50090-2510ValacyclovirValacyclovirA-S Medication SolutionsANDACurrent
50090-2575ValacyclovirValacyclovirA-S Medication SolutionsANDACurrent
50090-2575ValacyclovirValacyclovirA-S Medication SolutionsANDACurrent
50090-2575ValacyclovirValacyclovirA-S Medication SolutionsANDACurrent
50436-0704ValacyclovirValacyclovirUnit Dose ServicesANDACurrent
50436-7050ValacyclovirValacyclovirUnit Dose ServicesANDACurrent
50436-7050ValacyclovirValacyclovirUnit Dose ServicesANDACurrent
55700-913ValacyclovirValacyclovirQuality Care Products, LLCANDACurrent
55700-913ValacyclovirValacyclovirQuality Care Products, LLCANDACurrent
60760-469ValacyclovirValacyclovirSt. Mary's Medical Park PharmacyANDACurrent
63187-950ValacyclovirValacyclovirProficient Rx LPANDACurrent
63187-950ValacyclovirValacyclovirProficient Rx LPANDACurrent
63629-7958ValacyclovirValacyclovirBryant Ranch PrepackANDACurrent
63629-7958ValacyclovirValacyclovirBryant Ranch PrepackANDACurrent
63739-077ValacyclovirValacyclovirMcKesson Corporation dba SKY PackagingANDACurrent
67296-1297ValacyclovirValacyclovirRedPharm Drug, Inc.ANDACurrent
67296-1297ValacyclovirValacyclovirRedPharm Drug, Inc.ANDACurrent
68071-2753ValacyclovirValacyclovirNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3135ValacyclovirValacyclovirNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3135ValacyclovirValacyclovirNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3332ValacyclovirValacyclovirNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3332ValacyclovirValacyclovirNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4805ValacyclovirValacyclovirNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4805ValacyclovirValacyclovirNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7547ValacyclovirValacyclovirPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7587ValacyclovirValacyclovirPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7587ValacyclovirValacyclovirPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7587ValacyclovirValacyclovirPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7587ValacyclovirValacyclovirPreferred Pharmaceuticals, Inc.ANDACurrent
70518-2402ValacyclovirValacyclovirREMEDYREPACK INC.ANDACurrent
70518-2402ValacyclovirValacyclovirREMEDYREPACK INC.ANDACurrent
70518-2402ValacyclovirValacyclovirREMEDYREPACK INC.ANDACurrent
70518-2402ValacyclovirValacyclovirREMEDYREPACK INC.ANDACurrent
70934-106ValacyclovirValacyclovirDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-106ValacyclovirValacyclovirDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-106ValacyclovirValacyclovirDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0630ValacyclovirValacyclovirBryant Ranch PrepackANDACurrent
71335-0630ValacyclovirValacyclovirBryant Ranch PrepackANDACurrent
71335-0630ValacyclovirValacyclovirBryant Ranch PrepackANDACurrent
72189-051VALACYCLOVIRVALACYCLOVIRDIRECT RXANDACurrent
72189-051VALACYCLOVIRVALACYCLOVIRDIRECT RXANDACurrent
72189-051VALACYCLOVIRVALACYCLOVIRDIRECT RXANDACurrent
82009-040ValacyclovirValacyclovirQuallent Pharmaceuticals Health LLCANDACurrent
82009-040ValacyclovirValacyclovirQuallent Pharmaceuticals Health LLCANDACurrent
82009-041ValacyclovirValacyclovirQuallent Pharmaceuticals Health LLCANDACurrent
82009-041ValacyclovirValacyclovirQuallent Pharmaceuticals Health LLCANDACurrent