FDA.reportPublic FDA data

Application 079137

Type
ANDA
Sponsor
ZYDUS PHARMS

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
65841-629ValacyclovirValacyclovirCadila Healthcare LimitedANDACurrent
65841-629ValacyclovirValacyclovirCadila Healthcare LimitedANDACurrent
65841-629ValacyclovirValacyclovirZydus Lifesciences LimitedANDACurrent
65841-629ValacyclovirValacyclovirCadila Healthcare LimitedANDACurrent
65841-630ValacyclovirValacyclovirCadila Healthcare LimitedANDACurrent
65841-630ValacyclovirValacyclovirCadila Healthcare LimitedANDACurrent
65841-630ValacyclovirValacyclovirZydus Lifesciences LimitedANDACurrent
65841-630ValacyclovirValacyclovirCadila Healthcare LimitedANDACurrent
68382-225ValacyclovirValacyclovirZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-225ValacyclovirValacyclovirZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-226ValacyclovirValacyclovirZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-226ValacyclovirValacyclovirZydus Pharmaceuticals (USA) Inc.ANDACurrent