FDA.reportPublic FDA data

Application 205166

Type
ANDA
Sponsor
HETERO LABS LTD V

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VALGANCICLOVIR HYDROCHLORIDEVALGANCICLOVIR HYDROCHLORIDETABLET;ORALEQ 450MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6796ValganciclovirValganciclovirMajor PharmaceuticalsANDACurrent
0904-6796ValganciclovirValganciclovirMajor PharmaceuticalsANDACurrent
0904-6796ValganciclovirValganciclovirMajor PharmaceuticalsANDACurrent
31722-832ValganciclovirValganciclovirCamber Pharmaceuticals, Inc.ANDACurrent
31722-832ValganciclovirValganciclovirCamber Pharmaceuticals, Inc.ANDACurrent
50268-787ValganciclovirValganciclovirAvPAKANDACurrent
50268-787ValganciclovirValganciclovirAvPAKANDACurrent
50268-787ValganciclovirValganciclovirAvPAKANDACurrent
63739-076ValganciclovirValganciclovirMcKesson Corporation DBA SKY PackagingANDACurrent
63739-076ValganciclovirValganciclovirMcKesson Corporation DBA SKY PackagingANDACurrent