FDA.reportPublic FDA data

Application 211798

Type
ANDA
Sponsor
ALKEM LABS LTD

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
67877-613TizanidineTizanidineAscend Laboratories, LLCANDACurrent
67877-613TizanidineTizanidineAscend Laboratories, LLCANDACurrent
67877-613TizanidineTizanidineAscend Laboratories, LLCANDACurrent
67877-614TizanidineTizanidineAscend Laboratories, LLCANDACurrent
67877-614TizanidineTizanidineAscend Laboratories, LLCANDACurrent
67877-614TizanidineTizanidineAscend Laboratories, LLCANDACurrent