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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211066
Company: ALEMBIC PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VORTIOXETINE VORTIOXETINE 5MG TABLET;ORAL None (Tentative Approval) None No No
VORTIOXETINE VORTIOXETINE 10MG TABLET;ORAL None (Tentative Approval) None No No
VORTIOXETINE VORTIOXETINE 15MG TABLET;ORAL None (Tentative Approval) None No No
VORTIOXETINE VORTIOXETINE 20MG TABLET;ORAL None (Tentative Approval) None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/05/2022 ORIG-1 Tentative Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211066Orig1s000TA_ltr.pdf
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