FDA.reportPublic FDA data

Application 040151

Type
ANDA
Sponsor
HI TECH PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATECODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDESYRUP;ORAL10MG/5ML;6.25MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
12634-909Promethazine Hydrochloride and Codeine PhosphatePromethazine Hydrochloride and Codeine PhosphateApotheca IncANDACurrent
17856-0804Promethazine Hydrochloride and Codeine PhosphatePromethazine Hydrochloride and Codeine PhosphateAtlantic Biologicals CorpsANDACurrent
50383-804Promethazine Hydrochloride and Codeine PhosphatePromethazine Hydrochloride and Codeine PhosphateAkornANDACurrent
50383-804Promethazine Hydrochloride and Codeine PhosphatePromethazine Hydrochloride and Codeine PhosphateHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-804Promethazine Hydrochloride and Codeine PhosphatePromethazine Hydrochloride and Codeine PhosphateAkornANDACurrent
50383-804Promethazine Hydrochloride and Codeine PhosphatePromethazine Hydrochloride and Codeine PhosphateHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-804Promethazine Hydrochloride and Codeine PhosphatePromethazine Hydrochloride and Codeine PhosphateAkornANDACurrent