FDA.reportPublic FDA data

Application 079012

Type
ANDA
Sponsor
TIME-CAP 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
49483-690Valacyclovir HydrochlorideValacyclovir HydrochlorideTIME CAP LABORATORIES, INC.ANDACurrent
49483-690Valacyclovir HydrochlorideValacyclovir HydrochlorideTIME CAP LABORATORIES, INC.ANDACurrent
49483-691Valacyclovir HydrochlorideValacyclovir HydrochlorideTIME CAP LABORATORIES, INC.ANDACurrent
49483-691Valacyclovir HydrochlorideValacyclovir HydrochlorideTIME CAP LABORATORIES, INC.ANDACurrent
55111-552Valacyclovir HydrochlorideValacyclovir HydrochlorideDr. Reddys Laboratories LimitedANDACurrent
55111-553Valacyclovir HydrochlorideValacyclovir HydrochlorideDr. Reddys Laboratories LimitedANDACurrent