FDA.reportPublic FDA data

Application 207579

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDETABLET;ORALEQ 75MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
53943-017RANITIDINERanitidineDISCOUNT DRUG MARTANDACurrent
58602-733RANITIDINERanitidineAurohealth LLCANDACurrent
58602-733RANITIDINERanitidineAurohealth LLCANDACurrent
58602-733RANITIDINERanitidineAurohealth LLCANDACurrent
58602-733RANITIDINERanitidineAurohealth LLCANDACurrent