# AMLODIPINE BESYLATE
> **ANDA210489** · Abbreviated New Drug Application (Generic) · Sponsor: IPCA LABS LTD · Approved 2026-09-22
## Drug
- **FDA Application Number:** ANDA210489
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** AMLODIPINE BESYLATE
- **Generic name:** Amlodipine Besylate
- **Active ingredients:** AMLODIPINE BESYLATE
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** IPCA LABS LTD
- **First approval:** 2026-09-22
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210489)
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