FDA Drug Application (078633) for BUPRENORPHINE HYDROCHLORIDE by ROXANE

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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



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