FRESENIUS MEDCL CARE: New drug application for CIENBY
FRESENIUS MEDCL CARE: New drug application for CIENBY. Dated 16 days ago, it is in the active follow-up window. Score 85/100. 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 | FRESENIUS MEDCL CARE |
| Product | CIENBY |
| Generic / ingredient | SODIUM CTIRATE |
| Approval | New drug application (NDA) |
| Application | NDA219455 |
| Decided | 2026-10-19 |
| Panel / class | SOLUTION, INJECTION |
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| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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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: 2026-10-19
- 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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85 / 100 Score
- Decided in the last 30 days.
- A new product launch.
What is the FdaApprovalPulse record for FRESENIUS MEDCL CARE?
The FDA approved CIENBY (NDA219455) for FRESENIUS MEDCL CARE on 2026-10-19: new drug application (NDA).
How does FRESENIUS MEDCL CARE compare to other FdaApprovalPulse records?
It is 16 days old, still within a typical 45-day follow-up window. Its Score of 85/100 puts it among the stronger signals in this feed.
FRESENIUS MEDCL CARE vs. top 3 peers
| Organization | Record date |
|---|---|
| FRESENIUS MEDCL CARE | 2026-10-19 |
| AVYXA HOLDINGS, LLC. | 2026-10-29 |
| GLAXOSMITHKLINE LLC | 2026-10-20 |
| ALCON LABS INC | 2026-10-16 |
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FdaApprovalPulse: New drug application (NDA)
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