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FDA ANDA · ANDA211101
VORTIOXETINE HYDROBROMIDE
Sponsor: MSN LABORATORIES PRIVATE LTD
APPLICATION
ANDA211101
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)
Products
VORTIOXETINE HYDROBROMIDENone (Tentative Approval)
VORTIOXETINE HYDROBROMIDE 20MG · TABLET · ORAL
VORTIOXETINE HYDROBROMIDENone (Tentative Approval)
VORTIOXETINE HYDROBROMIDE 10MG · TABLET · ORAL
Approval history
2025-11-03UNKNOWN · Original · standardTA
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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