FDA Drug Application (019011) for GOLYTELY by BRAINTREE

Back to FDA Applications sponsored by BRAINTREE

Application Number019011
Product Number001
FormFOR SOLUTION;ORAL
Dosage236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT
Product Market Status Prescription
Therapeutic Equivalence Evaluation Code AA Products in conventional dosage forms not presenting bioequivalence problems
Reference Drug
Drug NameGOLYTELY
Active IngredientPOLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS



Back to FDA Applications sponsored by BRAINTREE

Problems, Comments, Suggestions? Click here to contact Greg Thatcher

Please read my Disclaimer





Copyright (c) 2013 Thatcher Development Software, LLC. All rights reserved. No claim to original U.S. Gov't works.