← FDA Drug Approvals (Drugs@FDA)
DRONEDARONE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALKEM LABS LTD · Approved 2015-12-31
Drug application
- FDA Application #
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
- Authoritative
- Drugs@FDA application overview
- Machine
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