FDA.reportPublic FDA data

Application 090216

Type
ANDA
Sponsor
WOCKHARDT

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
53217-054VALACYCLOVIR HYDROCHLORIDEVALACYCLOVIR HYDROCHLORIDEAidarex Pharmaceuticals LLCANDACurrent
55648-152VALACYCLOVIR HYDROCHLORIDEVALACYCLOVIR HYDROCHLORIDEWockhardt LimitedANDACurrent
55648-153VALACYCLOVIR HYDROCHLORIDEVALACYCLOVIR HYDROCHLORIDEWockhardt LimitedANDACurrent
64679-152VALACYCLOVIR HYDROCHLORIDEVALACYCLOVIR HYDROCHLORIDEWockhardt USA LLC.ANDACurrent
64679-152VALACYCLOVIR HYDROCHLORIDEVALACYCLOVIR HYDROCHLORIDEWockhardt USA LLC.ANDACurrent
64679-152VALACYCLOVIR HYDROCHLORIDEVALACYCLOVIR HYDROCHLORIDEWockhardt USA LLC.ANDACurrent
64679-153VALACYCLOVIR HYDROCHLORIDEVALACYCLOVIR HYDROCHLORIDEWockhardt USA LLC.ANDACurrent
64679-153VALACYCLOVIR HYDROCHLORIDEVALACYCLOVIR HYDROCHLORIDEWockhardt USA LLC.ANDACurrent
64679-153VALACYCLOVIR HYDROCHLORIDEVALACYCLOVIR HYDROCHLORIDEWockhardt USA LLC.ANDACurrent
68788-9554VALACYCLOVIR HYDROCHLORIDEVALACYCLOVIR HYDROCHLORIDEPreferred Pharmaceuticals, Inc.ANDACurrent