APPLICATION
ANDA077653
TYPE
ANDA
ORIGINAL APPROVAL
2008-06-13
LATEST ACTION
2023-08-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
VENLAFAXINE HYDROCHLORIDEPrescription
VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE · TABLET · ORAL
VENLAFAXINE HYDROCHLORIDEPrescription
VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE · TABLET · ORAL
VENLAFAXINE HYDROCHLORIDEPrescription
VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE · TABLET · ORAL
VENLAFAXINE HYDROCHLORIDEPrescription
VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE · TABLET · ORAL
VENLAFAXINE HYDROCHLORIDEPrescription
VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE · TABLET · ORAL
Approval history
2023-08-21Labeling · Supplement 23 · standardAP
2021-09-21Labeling · Supplement 22 · standardAP
2020-04-14Labeling · Supplement 20 · standardAP
2017-01-04Labeling · Supplement 14 · standardAP
2016-11-25Labeling · Supplement 13 · standardAP
2014-07-18Labeling · Supplement 9 · standardAP
2014-06-17Labeling · Supplement 6 · standardAP
2012-09-19Labeling · Supplement 4 · standardAP
2010-03-11Labeling · Supplement 3AP
2009-05-14Labeling · Supplement 1AP
2008-06-13OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.