FDA Drug Application (203326) for BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE by ROXANE

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Application Number203326
Product Number001
FormTABLET;SUBLINGUAL
DosageEQ 2MG BASE;EQ 0.5MG BASE
Product Market Status Prescription
Therapeutic Equivalence Evaluation Code AB Products meeting necessary bioequivalence requirements
Reference Drug
Drug NameBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Active IngredientBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE



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