Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091272
Company: SUN PHARM

Products on ANDA 091272

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091272

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/18/2010	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
09/02/2025	SUPPL-33	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/02/2025	SUPPL-28	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
03/29/2019	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
03/29/2019	SUPPL-15	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
03/29/2019	SUPPL-14	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/10/2014	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/03/2014	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
06/26/2012	SUPPL-3	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.