FDA.reportPublic FDA data

Application 210021

Type
ANDA
Sponsor
CADILA PHARMS 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
63629-2466TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
63629-2466TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
63629-2467TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
63629-2467TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
63629-2494TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
63629-2494TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
71209-064Tizanidine hydrochlorideTizanidine hydrochlorideCadila Pharmaceuticals LimitedANDACurrent
71209-064Tizanidine hydrochlorideTizanidine hydrochlorideCadila Pharmaceuticals LimitedANDACurrent
71209-064Tizanidine hydrochlorideTizanidine hydrochlorideCadila Pharmaceuticals LimitedANDACurrent
71209-064Tizanidine hydrochlorideTizanidine hydrochlorideCadila Pharmaceuticals LimitedANDACurrent
71209-065Tizanidine hydrochlorideTizanidine hydrochlorideCadila Pharmaceuticals LimitedANDACurrent
71209-065Tizanidine hydrochlorideTizanidine hydrochlorideCadila Pharmaceuticals LimitedANDACurrent
71209-065Tizanidine hydrochlorideTizanidine hydrochlorideCadila Pharmaceuticals LimitedANDACurrent
71209-065Tizanidine hydrochlorideTizanidine hydrochlorideCadila Pharmaceuticals LimitedANDACurrent
71209-066Tizanidine hydrochlorideTizanidine hydrochlorideCadila Pharmaceuticals LimitedANDACurrent
71209-066Tizanidine hydrochlorideTizanidine hydrochlorideCadila Pharmaceuticals LimitedANDACurrent
71209-066Tizanidine hydrochlorideTizanidine hydrochlorideCadila Pharmaceuticals LimitedANDACurrent
71209-066Tizanidine hydrochlorideTizanidine hydrochlorideCadila Pharmaceuticals LimitedANDACurrent
72241-041Tizanidine hydrochlorideTizanidine hydrochlorideModavar Pharmaceuticals LLCANDACurrent
72241-042Tizanidine hydrochlorideTizanidine hydrochlorideModavar Pharmaceuticals LLCANDACurrent
72241-043Tizanidine hydrochlorideTizanidine hydrochlorideModavar Pharmaceuticals LLCANDACurrent
75834-207TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDENivagen Pharmaceuticals, Inc.ANDACurrent
75834-207TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDENivagen Pharmaceuticals, Inc.ANDACurrent
75834-208TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDENivagen Pharmaceuticals, Inc.ANDACurrent
75834-208TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDENivagen Pharmaceuticals, Inc.ANDACurrent
75834-209TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDENivagen Pharmaceuticals, Inc.ANDACurrent
75834-209TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDENivagen Pharmaceuticals, Inc.ANDACurrent