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AMIODARONE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: RUBICON RESEARCH · Approved 2008-11-06
Drug application
- FDA Application #
ANDA078578- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- AMIODARONE HYDROCHLORIDE
- Generic name
- AMIODARONE HYDROCHLORIDE
- Active ingredients
- AMIODARONE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- RUBICON RESEARCH
- Manufacturer
- Advagen Pharma Limited
- First approval
- 2008-11-06
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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