Otsuka Pharmaceutical Co Ltd · 66-66 · JAPAN
For Otsuka Pharmaceutical Co Ltd, import alert is 66-66; country is JAPAN; import alert name is "APIs That Appear To Be Misbranded Under 502(f)(1) Because They Do Not Meet The Requirements For The Labeling Exemptions In 21 CFR 201.122"; product is Agent for Schizophrenia | OPC-14597 - Agent | Mucosta; product code is 65 A - S 99 Memory Adjuvant, N.E.C., Active Pharm Ingred/Chems for Further Manuf | 65 A - S 99 Memory Adjuvant, N.E.C., Active Pharm Ingred/Chems for Further Manuf | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 04/02/2019; address is 2-27 3-Chome Otedori cho U , Koku-Machi; Chuo , Osaka, Osaka JAPAN, verified against its source on 2026-09-30.
- Firm
- Otsuka Pharmaceutical Co Ltd verified
- Import alert
- 66-66
- Import alert name
- "APIs That Appear To Be Misbranded Under 502(f)(1) Because They Do Not Meet The Requirements For The Labeling Exemptions In 21 CFR 201.122"
- Country
- JAPAN verified
- Address
- 2-27 3-Chome Otedori cho U , Koku-Machi; Chuo , Osaka, Osaka JAPAN verified
- Date published
- 04/02/2019 verified
- Product code
- 65 A - S 99 Memory Adjuvant, N.E.C., Active Pharm Ingred/Chems for Further Manuf | 65 A - S 99 Memory Adjuvant, N.E.C., Active Pharm Ingred/Chems for Further Manuf | 66 V - - 99 Miscellaneous Patent Medicines, Etc. each item verified
- Product
- Agent for Schizophrenia | OPC-14597 - Agent | Mucosta each item verified
- FDA notes
- 11/2/2000 | 11/2/2000 | 11/2/2000 each item verified
What the source says
Otsuka Pharmaceutical Co Ltd Date Published : 04/02/2019 2-27 3-Chome Otedori cho U , Koku-Machi; Chuo , Osaka, Osaka JAPAN
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
65 A - S 99 Memory Adjuvant, N.E.C., Active Pharm Ingred/Chems for Further Manuf Date Published: 04/02/2019 Desc: Agent for Schizophrenia Notes: 11/2/2000 65 A - S 99 Memory Adjuvant, N.E.C., Active Pharm Ingred/Chems for Further Manuf Date Published: 04/02/2019 Desc: OPC-14597 - Agent Notes: 11/2/2000 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 04/02/2019 Desc: Mucosta Notes: 11/2/2000
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_202.html