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FDA ANDA · ANDA076690

VENLAFAXINE HYDROCHLORIDE

Sponsor: TEVA

APPLICATION
ANDA076690
TYPE
ANDA
ORIGINAL APPROVAL
2006-08-03
LATEST ACTION
2023-08-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

VENLAFAXINE HYDROCHLORIDEPrescription
VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE · TABLET · ORAL
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

Approval history

2023-08-18Labeling · Supplement 30 · standardAP
2023-08-09Labeling · Supplement 29 · standardAP
2021-09-21Labeling · Supplement 27 · standardAP
2020-04-14Labeling · Supplement 23 · standardAP
2017-01-04Labeling · Supplement 22 · standardAP
2014-07-17Labeling · Supplement 20 · standard — Label ↗AP
2014-06-30Labeling · Supplement 18 · standardAP
2012-09-19Labeling · Supplement 17 · standardAP
2010-08-04Manufacturing (CMC) · Supplement 15AP
2010-03-15Labeling · Supplement 16AP
2009-07-22Labeling · Supplement 14AP
2009-01-27Labeling · Supplement 11AP
2008-08-13Labeling · Supplement 8AP
2008-08-13Labeling · Supplement 10AP
2008-02-05Labeling · Supplement 6AP
2008-02-05Labeling · Supplement 5AP
2007-07-12Labeling · Supplement 3AP
2006-08-03Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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