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FDA ANDA · ANDA211089

VORTIOXETINE

Sponsor: ALKEM LABS LTD

APPLICATION
ANDA211089
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)

Products

VORTIOXETINENone (Tentative Approval)
VORTIOXETINE 10MG · TABLET · ORAL
VORTIOXETINENone (Tentative Approval)
VORTIOXETINE 15MG · TABLET · ORAL
VORTIOXETINENone (Tentative Approval)
VORTIOXETINE 5MG · TABLET · ORAL
VORTIOXETINENone (Tentative Approval)
VORTIOXETINE 20MG · TABLET · ORAL

Approval history

2019-08-21UNKNOWN · 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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