FDA Drug Application (040027) for PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE by HI TECH PHARMA

Back to FDA Applications sponsored by HI TECH PHARMA

Application Number040027
Product Number001
FormSYRUP;ORAL
Dosage15MG/5ML;6.25MG/5ML
Product Market Status Prescription
Therapeutic Equivalence Evaluation Code AA Products in conventional dosage forms not presenting bioequivalence problems
Reference Drug
Drug NamePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
Active IngredientDEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE

Active IngredientCount
List of drugs with Active Ingredient DEXTROMETHORPHAN HYDROBROMIDE14
List of drugs with Active Ingredient PROMETHAZINE HYDROCHLORIDE39


Back to FDA Applications sponsored by HI TECH PHARMA