FDA.reportPublic FDA data

Application 210267

Type
ANDA
Sponsor
NOVAST LABS

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
50742-224TIZANIDINE HYDROCHLORIDEtizanidine hydrochlorideIngenus Pharmaceuticals, LLCANDACurrent
50742-224TIZANIDINE HYDROCHLORIDEtizanidine hydrochlorideIngenus Pharmaceuticals, LLCANDACurrent
50742-224TIZANIDINE HYDROCHLORIDEtizanidine hydrochlorideIngenus Pharmaceuticals, LLCANDACurrent
50742-225TIZANIDINE HYDROCHLORIDEtizanidine hydrochlorideIngenus Pharmaceuticals, LLCANDACurrent
50742-225TIZANIDINE HYDROCHLORIDEtizanidine hydrochlorideIngenus Pharmaceuticals, LLCANDACurrent
50742-225TIZANIDINE HYDROCHLORIDEtizanidine hydrochlorideIngenus Pharmaceuticals, LLCANDACurrent
50742-226TIZANIDINE HYDROCHLORIDEtizanidine hydrochlorideIngenus Pharmaceuticals, LLCANDACurrent
50742-226TIZANIDINE HYDROCHLORIDEtizanidine hydrochlorideIngenus Pharmaceuticals, LLCANDACurrent
50742-226TIZANIDINE HYDROCHLORIDEtizanidine hydrochlorideIngenus Pharmaceuticals, LLCANDACurrent
80425-0090ZanaflexTizanidine HCl 4mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0090Tizanidine HCLTizanidine HCLAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0090Tizanidine HCLTizanidine HCLAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent