UPSHER SMITH LABS: Generic drug approval for PREDNISOLONE ACETATE
UPSHER SMITH LABS: Generic drug approval for PREDNISOLONE ACETATE. Dated 38 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 | UPSHER SMITH LABS |
| Product | PREDNISOLONE ACETATE |
| Generic / ingredient | PREDNISOLONE ACETATE |
| Approval | Generic drug approval (ANDA) |
| Application | ANDA212778 |
| Decided | 2026-09-28 |
| Panel / class | SUSPENSION/DROPS, OPHTHALMIC |
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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: 2026-09-28
- 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 UPSHER SMITH LABS?
The FDA approved PREDNISOLONE ACETATE (ANDA212778) for UPSHER SMITH LABS on 2026-09-28: generic drug approval (ANDA).
How does UPSHER SMITH LABS compare to other FdaApprovalPulse records?
It is 38 days old, still within a typical 45-day follow-up window.
UPSHER SMITH LABS 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.