# ZYDUS: labeling supplement approved for MINOCYCLINE HYDROCHLORIDE

**Score:** 65/100

| Field | Value |
|---|---|
| Sponsor | ZYDUS |
| Product | MINOCYCLINE HYDROCHLORIDE |
| Generic / ingredient | MINOCYCLINE HYDROCHLORIDE |
| Approval | Drug labeling or REMS supplement |
| Application | ANDA063011 supplement 43 |
| Decided | 2026-10-19 |
| Panel / class | CAPSULE, ORAL |

## 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=063011). 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.