FDA Drug Application (078633) for BUPRENORPHINE HYDROCHLORIDE by ROXANE

Back to FDA Applications sponsored by ROXANE

Application Number078633
Product Number001
FormTABLET;SUBLINGUAL
DosageEQ 2MG BASE
Product Market Status Prescription
Therapeutic Equivalence Evaluation Code AB Products meeting necessary bioequivalence requirements
Reference Drug
Drug NameBUPRENORPHINE HYDROCHLORIDE
Active IngredientBUPRENORPHINE HYDROCHLORIDE

Active IngredientCount
List of drugs with Active Ingredient BUPRENORPHINE HYDROCHLORIDE9


Back to FDA Applications sponsored by ROXANE