FDA.reportPublic FDA data

Application 077405

Type
ANDA
Sponsor
PHARM ASSOC

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0121-0727RanitidineRANITIDINEPharmaceutical Associates, Inc.ANDACurrent
0121-0727RanitidineRANITIDINEPharmaceutical Associates, Inc.ANDACurrent
0121-4727RanitidineRANITIDINEPharmaceutical Associates, Inc.ANDACurrent
0121-4727RanitidineRANITIDINEPharmaceutical Associates, Inc.ANDACurrent
17856-0727RanitidineRanitidineATLANTIC BIOLOGICALS CORP.ANDACurrent
50436-0727RanitidineRANITIDINEUnit Dose ServicesANDACurrent
67296-1586RanitidineRanitidineRedPharm Drug, Inc.ANDACurrent
67296-1586RanitidineRanitidineRedPharm Drug, Inc.ANDACurrent
67296-1586RanitidineRanitidineRedPharm Drug, Inc.ANDACurrent
68788-7101RanitidineRANITIDINEPreferred Pharmaceuticals Inc.ANDACurrent