FDA.reportPublic FDA data

Application 208187

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDETABLET;ORALEQ 2MG BASENoNo
002TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDETABLET;ORALEQ 4MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70710-1104tizanidinetizanidineZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1104tizanidinetizanidineZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1105tizanidinetizanidineZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1105tizanidinetizanidineZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1335tizanidinetizanidineCadila Healthcare LimitedANDACurrent
70771-1335tizanidinetizanidineCadila Healthcare LimitedANDACurrent
70771-1335tizanidinetizanidineZydus Lifesciences LimitedANDACurrent
70771-1336tizanidinetizanidineCadila Healthcare LimitedANDACurrent
70771-1336tizanidinetizanidineCadila Healthcare LimitedANDACurrent
70771-1336tizanidinetizanidineZydus Lifesciences LimitedANDACurrent
72578-096tizanidinetizanidineViona Pharmaceuticals IncANDACurrent
72578-097tizanidinetizanidineViona Pharmaceuticals IncANDACurrent