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FDA ANDA · ANDA211146

VORTIOXETINE HYDROBROMIDE

Sponsor: ZYDUS PHARMS

APPLICATION
ANDA211146
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

VORTIOXETINE HYDROBROMIDEDiscontinued
VORTIOXETINE HYDROBROMIDE EQ 20MG BASE · TABLET · ORAL
VORTIOXETINE HYDROBROMIDEDiscontinued
VORTIOXETINE HYDROBROMIDE EQ 5MG BASE · TABLET · ORAL
VORTIOXETINE HYDROBROMIDEDiscontinued
VORTIOXETINE HYDROBROMIDE EQ 10MG BASE · TABLET · ORAL

Approval history

2024-04-02UNKNOWN · Original · standardLetterTA
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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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