APPLICATION
ANDA078554
TYPE
ANDA
ORIGINAL APPROVAL
2009-01-09
LATEST ACTION
2023-08-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
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
VENLAFAXINE HYDROCHLORIDEPrescription
VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE · TABLET · ORAL
Approval history
2023-08-18Labeling · Supplement 13 · standardAP
2021-09-21Labeling · Supplement 10 · standardAP
2021-09-03Labeling · Supplement 8 · standardAP
2017-01-04Labeling · Supplement 6 · standardAP
2015-05-01Labeling · Supplement 5 · standardAP
2014-07-17Labeling · Supplement 4 · standardAP
2014-06-26Labeling · Supplement 2 · standardAP
2009-09-30Labeling · Supplement 1AP
2009-01-09OriginalAP
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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