FDA.reportPublic FDA data

Application 209859

Type
ANDA
Sponsor
AJANTA PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDECAPSULE;ORALEQ 150MG BASENoNo
002RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDECAPSULE;ORALEQ 300MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
27241-109RanitidineRanitidineAjanta Pharma LimitedANDACurrent
27241-109RanitidineRanitidineAjanta Pharma LimitedANDACurrent
27241-109RanitidineRanitidineAjanta Pharma USA Inc.ANDACurrent
27241-110RanitidineRanitidineAjanta Pharma LimitedANDACurrent
27241-110RanitidineRanitidineAjanta Pharma LimitedANDACurrent
27241-110RanitidineRanitidineAjanta Pharma USA Inc.ANDACurrent
70518-2633RanitidineRanitidineREMEDYREPACK INC.ANDACurrent
70518-2633RanitidineRanitidineREMEDYREPACK INC.ANDACurrent
70518-2633RanitidineRanitidineREMEDYREPACK INC.ANDACurrent