← FDA Drug Approvals (Drugs@FDA)
ANDA218862
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AMNEAL EU LTD · Approved 2025-01-16
Drug application
- FDA Application #
ANDA218862
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- —
- Generic name
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- Active ingredients
- —
- Dosage form
- —
- Route
- —
- Marketing status
- —
- Sponsor
- AMNEAL EU LTD
- First approval
- 2025-01-16
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown