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VORTIOXETINE HYDROBROMIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MSN LABORATORIES PRIVATE LTD · Approved 2025-11-03

Drug application

FDA Application #
ANDA211101
Application type
Abbreviated New Drug Application (Generic)
Brand name
VORTIOXETINE HYDROBROMIDE
Generic name
Vortioxetine Hydrobromide
Active ingredients
VORTIOXETINE HYDROBROMIDE
Dosage form
TABLET
Route
ORAL
Marketing status
None (Tentative Approval)
Sponsor
MSN LABORATORIES PRIVATE LTD
First approval
2025-11-03

Source

Authoritative
Drugs@FDA application overview
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