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The reconstituted extended-release injectable suspension is a uniform, homogeneous suspension that is opaque and milky-white in color.
Aripiprazole is an atypical antipsychotic which is present in ABILIFY MAINTENA as its monohydrate polymorphic form. Aripiprazole monohydrate is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl] butoxy]-3,4 dihydrocarbostyril monohydrate. The empirical formula is C23H27Cl2N3O2·H2O and its molecular weight is 466.40.
ABILIFY MAINTENA (aripiprazole) is an extended-release injectable suspension available in 400-mg or 300-mg strength pre-filled dual chamber syringes. The labeled strengths are calculated based on the anhydrous form (aripiprazole).
Excipients/Inactive Ingredients: Inactive ingredients (per administered dose) for 400 mg and 300 mg strength products, respectively, include carboxymethyl cellulose sodium (16.64 mg and 12.48 mg), mannitol (83.2 mg and 62.4 mg), sodium phosphate monobasic monohydrate (1.48 mg and 1.11 mg) and sodium hydroxide (pH adjuster).
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