# AMIODARONE HYDROCHLORIDE
> **ANDA077161** · Abbreviated New Drug Application (Generic) · Sponsor: GLAND PHARMA LTD · Approved 2005-04-20
## Drug
- **FDA Application Number:** ANDA077161
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** AMIODARONE HYDROCHLORIDE
- **Generic name:** AMIODARONE HYDROCHLORIDE
- **Active ingredients:** AMIODARONE HYDROCHLORIDE
- **Dosage form:** INJECTABLE
- **Route:** INJECTION
- **Marketing status:** Prescription
- **Sponsor:** GLAND PHARMA LTD
- **Manufacturer:** Gland Pharma Limited
- **First approval:** 2005-04-20
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=077161)
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