FDA.reportPublic FDA data

Application 206606

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACYCLOVIR SODIUMACYCLOVIR SODIUMINJECTABLE;INJECTIONEQ 500MG BASE/VIALNoNo
002ACYCLOVIR SODIUMACYCLOVIR SODIUMINJECTABLE;INJECTIONEQ 1GM BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68382-125acyclovirACYCLOVIRZydus Pharmaceuticals USA Inc.ANDACurrent
68382-125acyclovirACYCLOVIRZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-125acyclovirACYCLOVIRZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-126acyclovirACYCLOVIRZydus Pharmaceuticals USA Inc.ANDACurrent
68382-126acyclovirACYCLOVIRZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-126acyclovirACYCLOVIRZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1081acyclovirACYCLOVIRZydus Lifesciences LimitedANDACurrent
70771-1081acyclovirACYCLOVIRCadila Healthcare LimitedANDACurrent
70771-1081acyclovirACYCLOVIRCadila Healthcare LimitedANDACurrent
70771-1082acyclovirACYCLOVIRZydus Lifesciences LimitedANDACurrent
70771-1082acyclovirACYCLOVIRCadila Healthcare LimitedANDACurrent
70771-1082acyclovirACYCLOVIRCadila Healthcare LimitedANDACurrent