# AMLODIPINE BESYLATE
> **ANDA078226** · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS PHARMS USA · Approved 2007-07-09
## Drug
- **FDA Application Number:** ANDA078226
- **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:** ZYDUS PHARMS USA
- **Manufacturer:** Zydus Pharmaceuticals USA Inc.
- **First approval:** 2007-07-09
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=078226)
---
*AI Analytics · CC0 1.0*