FDA.reportPublic FDA data

Application 203845

Type
ANDA
Sponsor
CADILA PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDETABLET;ORAL25MGNoNo
002HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDETABLET;ORAL50MGNoNo
003HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDETABLET;ORAL100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70518-1581HydralazineHYDRALAZINE HYDROCHLORIDEREMEDYREPACK INC.ANDACurrent
70518-1581HydralazineHYDRALAZINE HYDROCHLORIDEREMEDYREPACK INC.ANDACurrent
71209-016HYDRALAZINE HYDROCHLORIDEhydralazine hydrochlorideCadila Pharmaceuticals LimitedANDACurrent
71209-016HYDRALAZINE HYDROCHLORIDEhydralazine hydrochlorideCadila Pharmaceuticals LimitedANDACurrent
71209-016HYDRALAZINE HYDROCHLORIDEhydralazine hydrochlorideCadila Pharmaceuticals LimitedANDACurrent
71209-016HYDRALAZINE HYDROCHLORIDEhydralazine hydrochlorideCadila Pharmaceuticals LimitedANDACurrent
71209-017HYDRALAZINE HYDROCHLORIDEhydralazine hydrochlorideCadila Pharmaceuticals LimitedANDACurrent
71209-017HYDRALAZINE HYDROCHLORIDEhydralazine hydrochlorideCadila Pharmaceuticals LimitedANDACurrent
71209-017HYDRALAZINE HYDROCHLORIDEhydralazine hydrochlorideCadila Pharmaceuticals LimitedANDACurrent
71209-017HYDRALAZINE HYDROCHLORIDEhydralazine hydrochlorideCadila Pharmaceuticals LimitedANDACurrent
71209-018HYDRALAZINE HYDROCHLORIDEhydralazine hydrochlorideCadila Pharmaceuticals LimitedANDACurrent
71209-018HYDRALAZINE HYDROCHLORIDEhydralazine hydrochlorideCadila Pharmaceuticals LimitedANDACurrent
71209-018HYDRALAZINE HYDROCHLORIDEhydralazine hydrochlorideCadila Pharmaceuticals LimitedANDACurrent
71209-018HYDRALAZINE HYDROCHLORIDEhydralazine hydrochlorideCadila Pharmaceuticals LimitedANDACurrent
72241-004HYDRALAZINE HYDROCHLORIDEhydralazine hydrochlorideModavar Pharmaceuticals LLCANDACurrent
72241-005HYDRALAZINE HYDROCHLORIDEhydralazine hydrochlorideModavar Pharmaceuticals LLCANDACurrent
72241-006HYDRALAZINE HYDROCHLORIDEhydralazine hydrochlorideModavar Pharmaceuticals LLCANDACurrent
75834-126HydralazineHYDRALAZINE HYDROCHLORIDENivagen Pharmaceuticals, Inc.ANDACurrent
75834-126HydralazineHYDRALAZINE HYDROCHLORIDENivagen Pharmaceuticals, Inc.ANDACurrent
75834-126HydralazineHYDRALAZINE HYDROCHLORIDENivagen Pharmaceuticals, Inc.ANDACurrent
75834-127HydralazineHYDRALAZINE HYDROCHLORIDENivagen Pharmaceuticals, Inc.ANDACurrent
75834-127HydralazineHYDRALAZINE HYDROCHLORIDENivagen Pharmaceuticals, Inc.ANDACurrent
75834-127HydralazineHYDRALAZINE HYDROCHLORIDENivagen Pharmaceuticals, Inc.ANDACurrent
75834-128HydralazineHYDRALAZINE HYDROCHLORIDENivagen Pharmaceuticals, Inc.ANDACurrent
75834-128HydralazineHYDRALAZINE HYDROCHLORIDENivagen Pharmaceuticals, Inc.ANDACurrent
75834-128HydralazineHYDRALAZINE HYDROCHLORIDENivagen Pharmaceuticals, Inc.ANDACurrent