FDA Drug Application (206319) for CHOLINE C-11 by GLOBAL ISOTOPES LLC

Back to FDA Applications sponsored by GLOBAL ISOTOPES LLC

Application Number206319
Product Number001
FormINJECTABLE;INTRAVENOUS
Dosage4-33.1mCi/ML
Product Market Status Prescription
Therapeutic Equivalence Evaluation Code AP Injectable aqueous solutions and, in certain instances, intravenous non-aqueous solutions
Reference Drug
Drug NameCHOLINE C-11
Active IngredientCHOLINE C-11



Back to FDA Applications sponsored by GLOBAL ISOTOPES LLC