← FDA Drug Approvals (Drugs@FDA)
AMIODARONE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: GLAND PHARMA LTD · Approved 2005-04-20
Drug application
- FDA Application #
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
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown