# PPI-DAC: manufacturing (CMC) supplement approved for POLYETHYLENE GLYCOL 3350

**Score:** 40/100

| Field | Value |
|---|---|
| Sponsor | PPI-DAC |
| Product | POLYETHYLENE GLYCOL 3350 |
| Generic / ingredient | POLYETHYLENE GLYCOL 3350 |
| Approval | Drug manufacturing (CMC) supplement |
| Application | ANDA090685 supplement 19 |
| Decided | 2026-08-18 |
| Panel / class | FOR SOLUTION, 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=090685). Last refreshed: 2026-11-03T05:14:00.980Z.
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.