DEXCEL: labeling supplement approved for TOFACITINIB CITRATE
DEXCEL: labeling supplement approved for TOFACITINIB CITRATE. Dated 9 days ago, it is in the active follow-up window. Score 65/100. As of 2026-11-03, 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 | DEXCEL |
| Product | TOFACITINIB CITRATE |
| Generic / ingredient | TOFACITINIB CITRATE |
| Approval | Drug labeling or REMS supplement |
| Application | ANDA218668 supplement 5 |
| Decided | 2026-10-26 |
| Panel / class | TABLET, EXTENDED RELEASE, ORAL |
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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: 2026-10-26
- Data refreshed: 2026-11-03
- 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: Tue, 03 Nov 2026 05:14:00 GMT
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65 / 100 Score
- Decided in the last 30 days.
- New labeling to print and distribute.
What is the FdaApprovalPulse record for DEXCEL?
The FDA approved TOFACITINIB CITRATE (ANDA218668 supplement 5) for DEXCEL on 2026-10-26: drug labeling or REMS supplement.
How does DEXCEL compare to other FdaApprovalPulse records?
It is fresh: dated 9 days ago, inside the window where early outreach matters most.
DEXCEL vs. top 3 peers
| Organization | Record date |
|---|---|
| DEXCEL | 2026-10-26 |
| NOVARTIS | 2026-10-28 |
| ACTELION | 2026-10-27 |
| NATCO PHARMA LTD | 2026-10-27 |
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From openFDA (PMA and Drugs@FDA). openFDA can lag FDA decisions by days to weeks. Drug supplement types follow the FDA submission class (labeling and REMS, manufacturing/CMC, efficacy, other). Company and product level only. Verify on FDA databases before relying on an approval.