FDA.reportPublic FDA data

Application 206535

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68382-048acyclovirACYCLOVIRZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-048acyclovirACYCLOVIRZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-048acyclovirACYCLOVIRZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-048acyclovirACYCLOVIRZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-048acyclovirACYCLOVIRZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-049acyclovirACYCLOVIRZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-049acyclovirACYCLOVIRZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-049acyclovirACYCLOVIRZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-049acyclovirACYCLOVIRZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-049acyclovirACYCLOVIRZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1383acyclovirACYCLOVIRCadila Healthcare LimitedANDACurrent
70771-1383acyclovirACYCLOVIRCadila Healthcare LimitedANDACurrent
70771-1383acyclovirACYCLOVIRCadila Healthcare LimitedANDACurrent
70771-1383acyclovirACYCLOVIRCadila Healthcare LimitedANDACurrent
70771-1383acyclovirACYCLOVIRZydus Lifesciences LimitedANDACurrent
70771-1383acyclovirACYCLOVIRCadila Healthcare LimitedANDACurrent
70771-1384acyclovirACYCLOVIRCadila Healthcare LimitedANDACurrent
70771-1384acyclovirACYCLOVIRCadila Healthcare LimitedANDACurrent
70771-1384acyclovirACYCLOVIRZydus Lifesciences LimitedANDACurrent
70771-1384acyclovirACYCLOVIRCadila Healthcare LimitedANDACurrent
70771-1384acyclovirACYCLOVIRCadila Healthcare LimitedANDACurrent
70771-1384acyclovirACYCLOVIRCadila Healthcare LimitedANDACurrent