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FDA ANDA · ANDA079098

VENLAFAXINE HYDROCHLORIDE

Sponsor: AMNEAL PHARMS

APPLICATION
ANDA079098
TYPE
ANDA
ORIGINAL APPROVAL
2010-05-11
LATEST ACTION
2023-08-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

VENLAFAXINE HYDROCHLORIDEDiscontinued
VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE · TABLET · ORAL
VENLAFAXINE HYDROCHLORIDEDiscontinued
VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE · TABLET · ORAL
VENLAFAXINE HYDROCHLORIDEDiscontinued
VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE · TABLET · ORAL
VENLAFAXINE HYDROCHLORIDEDiscontinued
VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE · TABLET · ORAL
VENLAFAXINE HYDROCHLORIDEDiscontinued
VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE · TABLET · ORAL

Approval history

2023-08-18Labeling · Supplement 17 · standardAP
2023-08-11Labeling · Supplement 16 · standardAP
2021-09-20Labeling · Supplement 13 · standardAP
2020-04-10Labeling · Supplement 8 · standardAP
2017-01-04Labeling · Supplement 5 · standardAP
2014-07-17Labeling · Supplement 3 · standardAP
2014-07-11Labeling · Supplement 2 · standardAP
2012-09-24Labeling · Supplement 1 · standardAP
2010-05-11OriginalAP
VIEW ON DRUGS@FDA ↗

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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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