Pharmaceutical companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Otsuka. FDA records under 2 spellings of its name, each linked to the record. See the Otsuka group view.
As of Nov 15, 2026, FDA's public records list Otsuka Pharmaceutical Development & Commercialization, Inc. with 2 drug recalls and 1 OPDP letter. The most recent is an OPDP letter dated Oct 31, 2023: Untitled letter: Rexulti.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 31, 2023 | Untitled letter: RexultiOffice of Prescription Drug Promotion | OPDP letters |
| Sep 17, 2018 | treatNOW ABILIFY (aripiprazole) / ABILIFY MAINTENA 400-mg (aripiprazole) for extended release injectable suspension. Kit contents 2 packs AbClass III · Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabeled. Product name is mis | Drug recalls |
| Sep 17, 2018 | treatNOW ABILIFY (aripiprazole) and ABILIFY MAINTENA (aripiprazole) 400MG for extended release injectable suspension. Kit Contents: 2 packs Class III · Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabeled. Product name is mis | Drug recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
