ACTAVIS LABS FL INC: labeling supplement approved for NAPROXEN SODIUM
ACTAVIS LABS FL INC: labeling supplement approved for NAPROXEN SODIUM. Dated 17 days ago, it is in the active follow-up window. Score 65/100. 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 | ACTAVIS LABS FL INC |
| Product | NAPROXEN SODIUM |
| Generic / ingredient | NAPROXEN SODIUM |
| Approval | Drug labeling or REMS supplement |
| Application | ANDA075416 supplement 24 |
| Decided | 2026-10-19 |
| 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: 2026-10-19
- 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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65 / 100 Score
- Decided in the last 30 days.
- New labeling to print and distribute.
What is the FdaApprovalPulse record for ACTAVIS LABS FL INC?
The FDA approved NAPROXEN SODIUM (ANDA075416 supplement 24) for ACTAVIS LABS FL INC on 2026-10-19: drug labeling or REMS supplement.
How does ACTAVIS LABS FL INC compare to other FdaApprovalPulse records?
It is 17 days old, still within a typical 45-day follow-up window.
ACTAVIS LABS FL INC vs. top 3 peers
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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.