FDA.reportPublic FDA data

Application 077655

Type
ANDA
Sponsor
TEVA 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
0093-7258ValacyclovirValacyclovirTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7259ValacyclovirValacyclovirTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7259ValacyclovirValacyclovirTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7259ValacyclovirValacyclovirTeva Pharmaceuticals USA, Inc.ANDACurrent
53808-0635Valacyclovir HydrochlorideValacyclovir HydrochlorideState of Florida DOH Central PharmacyANDACurrent
66116-516Valacyclovir HydrochlorideValacyclovir HydrochlorideMedVantx, Inc.ANDACurrent
68071-3372ValacyclovirValacyclovirNuCare Pharmaceuticals,Inc.ANDACurrent