OTSUKA PHARMACEUTICAL CO LTD: New drug application for SIMTRIYO
OTSUKA PHARMACEUTICAL CO LTD: New drug application for SIMTRIYO. Dated 103 days ago, it serves as a historical benchmark. Score 55/100. As of 2026-11-04, from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
Free preview: all 7 published fields of this record are shown below. Locked: 499 related FdaApprovalPulse records and the 4-column CSV export.
| Field | Value |
|---|---|
| Sponsor | OTSUKA PHARMACEUTICAL CO LTD |
| Product | SIMTRIYO |
| Generic / ingredient | CENTANAFADINE HYDROCHLORIDE |
| Approval | New drug application (NDA) |
| Application | NDA218145 |
| Decided | 2026-07-24 |
| Panel / class | CAPSULE, EXTENDED RELEASE |
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CSV columns: Sponsor · Product · Approval · Decided · official source URL
- Source agency: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
- Record date: 2026-07-24
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 06:06:18 GMT
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55 / 100 Score
- A new product launch.
What is the FdaApprovalPulse record for OTSUKA PHARMACEUTICAL CO LTD?
The FDA approved SIMTRIYO (NDA218145) for OTSUKA PHARMACEUTICAL CO LTD on 2026-07-24: new drug application (NDA).
How does OTSUKA PHARMACEUTICAL CO LTD compare to other FdaApprovalPulse records?
It is 103 days old; check the official source for later updates before acting.
OTSUKA PHARMACEUTICAL CO LTD vs. top 3 peers
| Organization | Record date |
|---|---|
| OTSUKA PHARMACEUTICAL CO LTD | 2026-07-24 |
| AVYXA HOLDINGS, LLC. | 2026-10-29 |
| GLAXOSMITHKLINE LLC | 2026-10-20 |
| FRESENIUS MEDCL CARE | 2026-10-19 |
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