AMPHASTAR PHARMS INC: efficacy supplement approved for REXTOVY
AMPHASTAR PHARMS INC: efficacy supplement approved for REXTOVY. Dated 142 days ago, it serves as a historical benchmark. Score 45/100. 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 | AMPHASTAR PHARMS INC |
| Product | REXTOVY |
| Generic / ingredient | NALOXONE HYDROCHLORIDE |
| Approval | Drug efficacy supplement (new indication or use) |
| Application | NDA208969 supplement 2 |
| Decided | 2026-06-16 |
| Panel / class | SPRAY, METERED, NASAL |
| Peer records CSV (500 records) | 🔒 Click to unlock → |
| 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: 2026-06-16
- 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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45 / 100 Score
- New indication or use: a relaunch.
What is the FdaApprovalPulse record for AMPHASTAR PHARMS INC?
The FDA approved REXTOVY (NDA208969 supplement 2) for AMPHASTAR PHARMS INC on 2026-06-16: drug efficacy supplement (new indication or use).
How does AMPHASTAR PHARMS INC compare to other FdaApprovalPulse records?
It is 142 days old; check the official source for later updates before acting.
AMPHASTAR PHARMS INC vs. top 3 peers
| Organization | Record date |
|---|---|
| AMPHASTAR PHARMS INC | 2026-06-16 |
| SUN PHARMA GLOBAL | 2026-10-29 |
| PFIZER | 2026-10-26 |
| PFIZER | 2026-10-26 |
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FdaApprovalPulse: Drug efficacy supplement (new indication or use)
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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.