← FDA Drug Approvals (Drugs@FDA)
VORTIOXETINE HYDROBROMIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MACLEODS PHARMACEUTICALS LTD · Approved 2025-11-10
Drug application
- FDA Application #
ANDA211165- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- VORTIOXETINE HYDROBROMIDE
- Generic name
- Vortioxetine
- Active ingredients
- VORTIOXETINE
- Dosage form
- TABLET:FILM COATED
- Route
- —
- Marketing status
- None (Tentative Approval)
- Sponsor
- MACLEODS PHARMACEUTICALS LTD
- First approval
- 2025-11-10
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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