Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 079098
Company: AMNEAL PHARMS

Products on ANDA 079098

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET;ORAL	Discontinued	None	No	No
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET;ORAL	Discontinued	None	No	No
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET;ORAL	Discontinued	None	No	No
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET;ORAL	Discontinued	None	No	No
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 079098

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/11/2010	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/18/2023	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
08/11/2023	SUPPL-16	Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels		Label is not available on this site.
09/20/2021	SUPPL-13	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/10/2020	SUPPL-8	Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
01/04/2017	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
07/17/2014	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
07/11/2014	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
09/24/2012	SUPPL-1	Labeling-Package Insert		Label is not available on this site.