# DRONEDARONE HYDROCHLORIDE
> **ANDA205895** · Abbreviated New Drug Application (Generic) · Sponsor: ALKEM LABS LTD · Approved 2015-12-31
## Drug
- **FDA Application Number:** ANDA205895
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** DRONEDARONE HYDROCHLORIDE
- **Generic name:** Dronedarone Hydrochloride
- **Active ingredients:** DRONEDARONE HYDROCHLORIDE
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** None (Tentative Approval)
- **Sponsor:** ALKEM LABS LTD
- **First approval:** 2015-12-31
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205895)
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