FDA.reportPublic FDA data

Application 212196

Type
ANDA
Sponsor
ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDECAPSULE;ORALEQ 2MG BASENoNo
002TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDECAPSULE;ORALEQ 4MG BASENoNo
003TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDECAPSULE;ORALEQ 6MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63629-8871Tizanidne hydrochlorideTizanidne HydrochlorideBryant Ranch PrepackANDACurrent
63629-8871Tizanidne hydrochlorideTizanidne HydrochlorideBryant Ranch PrepackANDACurrent
63629-8871Tizanidne hydrochlorideTizanidne HydrochlorideBryant Ranch PrepackANDACurrent
63629-8872Tizanidne hydrochlorideTizanidne HydrochlorideBryant Ranch PrepackANDACurrent
63629-8872Tizanidne hydrochlorideTizanidne HydrochlorideBryant Ranch PrepackANDACurrent
63629-8872Tizanidne hydrochlorideTizanidne HydrochlorideBryant Ranch PrepackANDACurrent
63629-8873Tizanidne hydrochlorideTizanidne HydrochlorideBryant Ranch PrepackANDACurrent
63629-8873Tizanidne hydrochlorideTizanidne HydrochlorideBryant Ranch PrepackANDACurrent
63629-8873Tizanidne hydrochlorideTizanidne HydrochlorideBryant Ranch PrepackANDACurrent
67296-1793Tizanidne hydrochlorideTizanidne HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1793Tizanidne hydrochlorideTizanidne HydrochlorideRedPharm Drug, Inc.ANDACurrent
67877-610Tizanidne hydrochlorideTizanidne HydrochlorideAscend Laboratories, LLCANDACurrent
67877-610Tizanidne hydrochlorideTizanidne HydrochlorideAscend Laboratories, LLCANDACurrent
67877-610Tizanidne hydrochlorideTizanidne HydrochlorideAscend Laboratories, LLCANDACurrent
67877-611Tizanidne hydrochlorideTizanidne HydrochlorideAscend Laboratories, LLCANDACurrent
67877-611Tizanidne hydrochlorideTizanidne HydrochlorideAscend Laboratories, LLCANDACurrent
67877-611Tizanidne hydrochlorideTizanidne HydrochlorideAscend Laboratories, LLCANDACurrent
67877-612Tizanidne hydrochlorideTizanidne HydrochlorideAscend Laboratories, LLCANDACurrent
67877-612Tizanidne hydrochlorideTizanidne HydrochlorideAscend Laboratories, LLCANDACurrent
67877-612Tizanidne hydrochlorideTizanidne HydrochlorideAscend Laboratories, LLCANDACurrent
68788-7962Tizanidne hydrochlorideTizanidne HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7962Tizanidne hydrochlorideTizanidne HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
71335-2077Tizanidne hydrochlorideTizanidne HydrochlorideBryant Ranch PrepackANDACurrent
76420-231Tizanidne hydrochlorideTizanidne HydrochlorideAsclemed USA, Inc.ANDACurrent
80425-0144ZanaflexTizanidine 4mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0144Tizanidine HCLTizanidine HCLAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0144Tizanidine HCLTizanidine HCLAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0144Tizanidine HCLTizanidine HCLAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent