FDA.reportPublic FDA data

Application 078884

Type
ANDA
Sponsor
WOCKHARDT

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
55648-740RANITIDINERANITIDINEWOCKHARDT LIMITEDANDACurrent
59726-580RanitidineRanitidineP and L Development of New York CorporationANDACurrent
64679-740RANITIDINEranitidineWockhardt USA LLC.ANDACurrent