# MICRO LABS: manufacturing (CMC) supplement approved for DALFAMPRIDINE

**Score:** 40/100

| Field | Value |
|---|---|
| Sponsor | MICRO LABS |
| Product | DALFAMPRIDINE |
| Generic / ingredient | DALFAMPRIDINE |
| Approval | Drug manufacturing (CMC) supplement |
| Application | ANDA210158 supplement 9 |
| Decided | 2026-08-10 |
| Panel / class | TABLET, EXTENDED RELEASE, ORAL |

## Why this score
- Manufacturing change: sites, suppliers or process.

Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210158). Last refreshed: 2026-11-04T06:06:18.796Z.
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.