FDA.reportPublic FDA data

Application 078312

Type
ANDA
Sponsor
AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDESYRUP;ORALEQ 15MG BASE/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17856-0664RanitidineRanitidineAtlantic Biologicals CorpsANDACurrent
65162-664RanitidineRanitidineAmneal Pharmaceuticals LLCANDACurrent
65162-664RanitidineRanitidineAmneal Pharmaceuticals LLCANDACurrent
65162-664RanitidineRanitidineAmneal Pharmaceuticals LLCANDACurrent
65162-664RanitidineRanitidineAmneal Pharmaceuticals LLCANDACurrent
68094-204Ranitidine HydrochlorideRanitidine HydrochloridePrecision Dose Inc.ANDACurrent
68094-204Ranitidine HydrochlorideRanitidine HydrochloridePrecision Dose Inc.ANDACurrent
68094-204Ranitidine HydrochlorideRanitidine HydrochloridePrecision Dose Inc.ANDACurrent