# VORTIOXETINE HYDROBROMIDE
> **ANDA211165** · Abbreviated New Drug Application (Generic) · Sponsor: MACLEODS PHARMACEUTICALS LTD · Approved 2025-11-10
## Drug
- **FDA Application Number:** 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
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211165)
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