FDA.report

Application 076280

Type
ANDA
Sponsor
CASI PHARMS INC

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDETABLET;ORALEQ 2MG BASENoNo
002TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDETABLET;ORALEQ 4MG BASENoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0185-0034tizanidine hydrochloridetizanidine hydrochlorideEon Labs, Inc.ANDACurrent
0185-4400tizanidine hydrochloridetizanidine hydrochlorideEon Labs, Inc.ANDACurrent
43063-237Comfort Pac with TizanidineTizanidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-784tizanidine hydrochloridetizanidine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-784tizanidine hydrochloridetizanidine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-784tizanidine hydrochloridetizanidine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-784tizanidine hydrochloridetizanidine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-784tizanidine hydrochloridetizanidine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-784tizanidine hydrochloridetizanidine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
63629-6537tizanidine hydrochloridetizanidine hydrochlorideBryant Ranch PrepackANDACurrent
63629-6537tizanidine hydrochloridetizanidine hydrochlorideBryant Ranch PrepackANDACurrent
68788-6431tizanidine hydrochloridetizanidine hydrochloridePreferred PharmaceuticalsANDACurrent
71610-114tizanidine hydrochloridetizanidine hydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent