Otsuka Pharmaceutical
Pharmaceutical companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in JapanLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 6 spellings of its name, each linked to the record. See the Otsuka group view.
- Group recordsLabelled by a language model (which subsidiaries belong to the group) from the firm's FDA names. It is not an FDA field.: 36, 5 entities
- Drug applications: 19
- 510(k) clearances: 9
- Drug recalls: 6
- Complete response letters: 1
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Otsuka Pharmaceutical and its 4 subsidiaries
Latest Records
Newest first across sources; each opens the record| Date | Record | Source |
|---|---|---|
| Jun 30, 2025 | Otsuka Digital Feedback DeviceK251088 · OZW | 510(k) clearances |
| Mar 30, 2024 | RejoynK231209 · SAP | 510(k) clearances |
| Oct 31, 2023 | Untitled letter: RexultiOffice of Prescription Drug Promotion | OPDP letters |
| Aug 11, 2023 | Otsuka Digital Feedback Device-RWK223463 · OZW | 510(k) clearances |
| 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 |
| Jul 26, 2012 | Complete response letter, NDA 202971Approved | Complete response letters |
| Mar 9, 2010 | POC-AS10 AUTO SAMPLERK092817 · MSQ | 510(k) clearances |
| Nov 16, 2006 | RAPIRUN H. PYLORI ANTIBODY DETECTION KITK052716 · LYR | 510(k) clearances |
| Jul 15, 2004 | POCONE INFRARED SPECTROPHOTOMETERK041148 · MSQ | 510(k) clearances |
| Dec 21, 2001 | UBIT-IR300 INFRARED SPECTROMETRY SYSTEMK013371 · JJQ | 510(k) clearances |
| Jul 24, 2000 | RLP-CHOLESTEROL IMMUNOSEPARATION ASSAYK001032 · CHH | 510(k) clearances |
Subsidiaries and Divisions
4 firms in the Otsuka Pharmaceutical group, most records firstCanada and Imports
Across the Otsuka Pharmaceutical group, matched by company name- FDA import refusals since 2024
- 3 shipment lines, through Oct 23, 2026
Names and Identifiers
- Appears as
- Website
- otsuka.com
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