Complete Response Letters

Otsuka Pharmaceutical Company, Ltd.: ABILIFY MAINTENA

What FDA's Complete Response Letters to the company say, in the letters' own words.

EphemerisX Research · Sep 30, 2026 · Sources: FDA, SEC

Complete Response Letter, Jul 26, 2012

Act for ABILIFY MAINTENA (aripiprazole) extended-release injectable suspension for intramuscular (IM) injection 300 mg/vial and 400 mg/vial.

Complete Response Letter · Jul 26, 2012 · p. 1Open the letter at p. 1 ↗CRL_NDA202971_20120726:p1:s17

Please submit labeling identical to attached as agreed upon on July 18, 2012.

Complete Response Letter · Jul 26, 2012 · p. 1Open the letter at p. 1 ↗CRL_NDA202971_20120726:p1:s32

Updated Sep 30, 2026 · built from 283 companies in the EphemerisX knowledge graph. This page is regenerated as companies are added.