ACCORD BIOPHARMA INC.: bioequivalence supplement approved for IMULDOSA
ACCORD BIOPHARMA INC.: bioequivalence supplement approved for IMULDOSA. Dated 152 days ago, it serves as a historical benchmark. Score 30/100. 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 | ACCORD BIOPHARMA INC. |
| Product | IMULDOSA |
| Generic / ingredient | USTEKINUMAB-SRLF |
| Approval | Other drug supplement |
| Application | BLA761364 supplement 5 |
| Decided | 2026-06-05 |
| Panel / class | INJECTABLE, INTRAVENOUS |
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- Source agency: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
- Record date: 2026-06-05
- 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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30 / 100 Score
What is the FdaApprovalPulse record for ACCORD BIOPHARMA INC.?
The FDA approved IMULDOSA (BLA761364 supplement 5) for ACCORD BIOPHARMA INC. on 2026-06-05: other drug supplement.
How does ACCORD BIOPHARMA INC. compare to other FdaApprovalPulse records?
It is 152 days old; check the official source for later updates before acting. Its Score of 30/100 is modest; treat it as background rather than a priority.
ACCORD BIOPHARMA INC. vs. top 3 peers
| Organization | Record date |
|---|---|
| ACCORD BIOPHARMA INC. | 2026-06-05 |
| AMGEN INC | 2026-09-29 |
| TEVA PHARMACEUTICALS, INC. | 2026-09-29 |
| CELLTRION INC | 2026-09-29 |
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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.