Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091272
Company: SUN PHARM
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 Prescription AB No No
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 225MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
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
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-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/10/2014 SUPPL-10 Labeling-Package Insert, Labeling-Medication Guide

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-Package Insert, Labeling-Medication Guide

Label is not available on this site.

VENLAFAXINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL; EQ 37.5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022104 OSMOTICA PHARM
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091272 SUN PHARM

TABLET, EXTENDED RELEASE;ORAL; EQ 75MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211323 CADILA PHARMS LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022104 OSMOTICA PHARM
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091272 SUN PHARM

TABLET, EXTENDED RELEASE;ORAL; EQ 150MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211323 CADILA PHARMS LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 209193 DEXCEL PHARMA
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205468 NOSTRUM LABS INC
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022104 OSMOTICA PHARM
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091272 SUN PHARM

TABLET, EXTENDED RELEASE;ORAL; EQ 225MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 225MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211323 CADILA PHARMS LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 225MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 209193 DEXCEL PHARMA
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 225MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205468 NOSTRUM LABS INC
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 225MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022104 OSMOTICA PHARM
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 225MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091272 SUN PHARM

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