← FDA Drug Approvals (Drugs@FDA)
DRONEDARONE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA LTD · Approved 2023-04-27
Drug application
- FDA Application #
ANDA210678- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- DRONEDARONE
- Generic name
- Dronedarone
- Active ingredients
- DRONEDARONE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- None (Tentative Approval)
- Sponsor
- AUROBINDO PHARMA LTD
- First approval
- 2023-04-27
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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