Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090174
Company: ZYDUS PHARMS USA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE CAPSULE, 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
04/14/2011 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
01/20/2016 SUPPL-12 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

01/20/2016 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

01/20/2016 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

01/10/2014 SUPPL-8 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

09/19/2012 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

VENLAFAXINE HYDROCHLORIDE

CAPSULE, 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
EFFEXOR XR VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 020699 WYETH PHARMS
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 212277 ANNORA PHARMA
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 200834 AUROBINDO PHARMA LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078421 DR REDDYS LABS LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 201272 INTELLIPHARMACEUTICS
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 204889 MACLEODS PHARMS LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 091123 ORCHID HLTHCARE
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 076565 TEVA
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 090899 TORRENT PHARMS LLC
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 090071 VALEANT PHARMS NORTH
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078865 WOCKHARDT
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 090174 ZYDUS PHARMS USA INC

CAPSULE, 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
EFFEXOR XR VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 020699 WYETH PHARMS
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 212277 ANNORA PHARMA
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 200834 AUROBINDO PHARMA LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078421 DR REDDYS LABS LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 201272 INTELLIPHARMACEUTICS
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 204889 MACLEODS PHARMS LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 091123 ORCHID HLTHCARE
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 076565 TEVA
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 090899 TORRENT PHARMS LLC
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 090071 VALEANT PHARMS NORTH
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078865 WOCKHARDT
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 090174 ZYDUS PHARMS USA INC

CAPSULE, 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
EFFEXOR XR VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 020699 WYETH PHARMS
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 212277 ANNORA PHARMA
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 200834 AUROBINDO PHARMA LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078421 DR REDDYS LABS LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 201272 INTELLIPHARMACEUTICS
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 204889 MACLEODS PHARMS LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 091123 ORCHID HLTHCARE
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 076565 TEVA
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 090899 TORRENT PHARMS LLC
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 090071 VALEANT PHARMS NORTH
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078865 WOCKHARDT
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 090174 ZYDUS PHARMS USA INC

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