FDA.reportPublic FDA data

Application 076347

Type
ANDA
Sponsor
EPIC PHARMA LLC

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
21695-126TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDERebel DistributorsANDACurrent
21695-127TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDERebel DistributorsANDACurrent
35356-662TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-662TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-662TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
68387-130TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEKeltman Pharmaceuticals Inc.ANDACurrent
68387-140TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEKeltman Pharmaceuticals Inc.ANDACurrent