FDA.reportPublic FDA data

Application 090370

Type
ANDA
Sponsor
WATSON LABS INC

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
43063-534Valacyclovir hydrochlorideValacyclovir hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
45963-558Valacyclovir hydrochlorideValacyclovir hydrochlorideActavis Pharma, Inc.ANDACurrent
45963-559Valacyclovir hydrochlorideValacyclovir hydrochlorideActavis Pharma, Inc.ANDACurrent
51655-955Valacyclovir HydrochlorideValacyclovir HydrochlorideNorthwind PharmaceuticalsANDACurrent
63187-311Valacyclovir hydrochlorideValacyclovir hydrochlorideProficient Rx LPANDACurrent
68071-4040Valacyclovir hydrochlorideValacyclovir hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent