FDA Drug Application (018401) for BUPRENEX by INDIVIOR INC

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Application Number018401
Product Number001
FormINJECTABLE;INJECTION
DosageEQ 0.3MG BASE/ML
Product Market Status Prescription
Therapeutic Equivalence Evaluation Code AP Injectable aqueous solutions and, in certain instances, intravenous non-aqueous solutions
Reference Drug
Drug NameBUPRENEX
Active IngredientBUPRENORPHINE HYDROCHLORIDE



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