FDA Drug Application (200386) for PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE by TRIS PHARMA INC

Back to FDA Applications sponsored by TRIS PHARMA INC

Application Number200386
Product Number001
FormSYRUP;ORAL
Dosage10MG/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 CODEINE PHOSPHATE
Active IngredientCODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE

Active IngredientCount
List of drugs with Active Ingredient CODEINE PHOSPHATE51
List of drugs with Active Ingredient PROMETHAZINE HYDROCHLORIDE39


Back to FDA Applications sponsored by TRIS PHARMA INC