Application 091078

Type
ANDA
Sponsor
HI TECH PHARMA

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
50383-051RanitidineRanitidineHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-051RanitidineRanitidineHi-Tech Pharmacal Co., Inc.ANDACurrent