SOMERSET THERAPS LLC: Generic drug approval for VARENICLINE TARTRATE
SOMERSET THERAPS LLC: Generic drug approval for VARENICLINE TARTRATE. Dated 122 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 | SOMERSET THERAPS LLC |
| Product | VARENICLINE TARTRATE |
| Generic / ingredient | VARENICLINE TARTRATE |
| Approval | Generic drug approval (ANDA) |
| Application | ANDA219382 |
| Decided | 2026-07-06 |
| Panel / class | TABLET, 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: 2026-07-06
- 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
- A generic launch.
What is the FdaApprovalPulse record for SOMERSET THERAPS LLC?
The FDA approved VARENICLINE TARTRATE (ANDA219382) for SOMERSET THERAPS LLC on 2026-07-06: generic drug approval (ANDA).
How does SOMERSET THERAPS LLC compare to other FdaApprovalPulse records?
It is 122 days old; check the official source for later updates before acting.
SOMERSET THERAPS LLC vs. top 3 peers
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FdaApprovalPulse: Generic drug approval (ANDA)
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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.