# RISING: labeling supplement approved for METRONIDAZOLE IN PLASTIC CONTAINER

**Score:** 65/100

| Field | Value |
|---|---|
| Sponsor | RISING |
| Product | METRONIDAZOLE IN PLASTIC CONTAINER |
| Generic / ingredient | METRONIDAZOLE |
| Approval | Drug labeling or REMS supplement |
| Application | ANDA205531 supplement 3 |
| Decided | 2026-10-19 |
| Panel / class | INJECTABLE, INJECTION |

## Why this score
- Decided in the last 30 days.
- New labeling to print and distribute.

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=205531). 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.