FDA.reportPublic FDA data

Application 077478

Type
ANDA
Sponsor
SANDOZ

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
0781-5208Valacyclovir HydrochlorideValacyclovir HydrochlorideSandoz IncANDACurrent
0781-5208Valacyclovir HydrochlorideValacyclovir HydrochlorideSandoz Inc.ANDACurrent
0781-5208Valacyclovir HydrochlorideValacyclovir HydrochlorideSandoz Inc.ANDACurrent
0781-5208Valacyclovir HydrochlorideValacyclovir HydrochlorideSandoz Inc.ANDACurrent
0781-5209Valacyclovir HydrochlorideValacyclovir HydrochlorideSandoz IncANDACurrent
0781-5209Valacyclovir HydrochlorideValacyclovir HydrochlorideSandoz Inc.ANDACurrent
0781-5209Valacyclovir HydrochlorideValacyclovir HydrochlorideSandoz Inc.ANDACurrent
0781-5209Valacyclovir HydrochlorideValacyclovir HydrochlorideSandoz Inc.ANDACurrent
61919-919ValacyclovirValacyclovirDirect RxANDACurrent
68788-9432Valacyclovir HydrochlorideValacyclovir HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
70518-2329Valacyclovir HydrochlorideValacyclovir HydrochlorideREMEDYREPACK INC.ANDACurrent
75921-208VALACYCLOVIR HYDROCHLORIDEVALACYCLOVIR HYDROCHLORIDELife Line Home Care Services, Inc.ANDACurrent