FDA.reportPublic FDA data

Application 206743

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DARIFENACIN HYDROBROMIDEDARIFENACIN HYDROBROMIDETABLET, EXTENDED RELEASE;ORALEQ 7.5MG BASENoNo
002DARIFENACIN HYDROBROMIDEDARIFENACIN HYDROBROMIDETABLET, EXTENDED RELEASE;ORALEQ 15MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16571-767DarifenacinDarifenacinRising Pharma Holdings, Inc.ANDACurrent
16571-768DarifenacinDarifenacinRising Pharma Holdings, Inc.ANDACurrent
65862-861DarifenacinDarifenacinAurobindo Pharma LimitedANDACurrent
65862-861DarifenacinDarifenacinAurobindo Pharma LimitedANDACurrent
65862-861DarifenacinDarifenacinAurobindo Pharma LimitedANDACurrent
65862-862DarifenacinDarifenacinAurobindo Pharma LimitedANDACurrent
65862-862DarifenacinDarifenacinAurobindo Pharma LimitedANDACurrent
65862-862DarifenacinDarifenacinAurobindo Pharma LimitedANDACurrent