# IPCA LABS LTD: Generic drug approval for AMLODIPINE BESYLATE

**Score:** 45/100

| Field | Value |
|---|---|
| Sponsor | IPCA LABS LTD |
| Product | AMLODIPINE BESYLATE |
| Generic / ingredient | AMLODIPINE BESYLATE |
| Approval | Generic drug approval (ANDA) |
| Application | ANDA210489 |
| Decided | 2026-09-22 |
| Panel / class | TABLET, ORAL |

## Why this score
- A generic launch.

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=210489). Last refreshed: 2026-11-05T08:47:15.055Z.
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.