← FDA Drug Approvals (Drugs@FDA)
EDARAVONE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS PHARMS USA INC · Approved 2024-03-13
Drug application
- FDA Application #
ANDA218349
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- EDARAVONE
- Generic name
- Edaravone
- Active ingredients
- EDARAVONE
- Dosage form
- INJECTABLE
- Route
- INJECTION
- Marketing status
- None (Tentative Approval)
- Sponsor
- ZYDUS PHARMS USA INC
- First approval
- 2024-03-13
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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