Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076690
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET;ORAL Prescription AB No No
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET;ORAL Prescription AB No No
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET;ORAL Prescription AB No Yes
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET;ORAL Prescription AB No No
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET;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
08/03/2006 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076690s000LTR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/04/2017 SUPPL-22 Labeling-Package Insert

Label is not available on this site.

07/17/2014 SUPPL-20 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/076690s020lbl.pdf
06/30/2014 SUPPL-18 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/19/2012 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

03/15/2010 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

08/04/2010 SUPPL-15 Labeling-Container/Carton Labels

Label is not available on this site.

07/22/2009 SUPPL-14 Labeling

Label is not available on this site.

01/27/2009 SUPPL-11 Labeling

Label is not available on this site.

08/13/2008 SUPPL-10 Labeling

Label is not available on this site.

08/13/2008 SUPPL-8 Labeling

Label is not available on this site.

02/05/2008 SUPPL-6 Labeling

Label is not available on this site.

02/05/2008 SUPPL-5 Labeling

Label is not available on this site.

07/12/2007 SUPPL-3 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/17/2014 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/076690s020lbl.pdf

VENLAFAXINE HYDROCHLORIDE

TABLET;ORAL; EQ 25MG 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 25MG BASE TABLET;ORAL Prescription No AB 078932 ALEMBIC PHARMS LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET;ORAL Prescription No AB 079098 AMNEAL PHARMS
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET;ORAL Prescription No AB 090555 AUROBINDO PHARMA
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET;ORAL Prescription No AB 206250 CADILA PHARMS LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET;ORAL Prescription No AB 078301 DR REDDYS LABS LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET;ORAL Prescription No AB 078554 HERITAGE PHARMS INC
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET;ORAL Prescription No AB 077166 MYLAN
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET;ORAL Prescription No AB 078627 SUN PHARM INDS INC
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET;ORAL Prescription No AB 076690 TEVA
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET;ORAL Prescription No AB 202036 YAOPHARMA CO LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET;ORAL Prescription No AB 077653 ZYDUS PHARMS USA

TABLET;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;ORAL Prescription No AB 078932 ALEMBIC PHARMS LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET;ORAL Prescription No AB 079098 AMNEAL PHARMS
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET;ORAL Prescription No AB 090555 AUROBINDO PHARMA
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET;ORAL Prescription No AB 206250 CADILA PHARMS LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET;ORAL Prescription No AB 078301 DR REDDYS LABS LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET;ORAL Prescription No AB 078554 HERITAGE PHARMS INC
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET;ORAL Prescription No AB 077166 MYLAN
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET;ORAL Prescription No AB 078627 SUN PHARM INDS INC
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET;ORAL Prescription No AB 076690 TEVA
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET;ORAL Prescription No AB 202036 YAOPHARMA CO LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET;ORAL Prescription No AB 077653 ZYDUS PHARMS USA

TABLET;ORAL; EQ 50MG 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 50MG BASE TABLET;ORAL Prescription No AB 078932 ALEMBIC PHARMS LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET;ORAL Prescription No AB 079098 AMNEAL PHARMS
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET;ORAL Prescription No AB 090555 AUROBINDO PHARMA
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET;ORAL Prescription No AB 206250 CADILA PHARMS LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET;ORAL Prescription No AB 078301 DR REDDYS LABS LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET;ORAL Prescription No AB 078554 HERITAGE PHARMS INC
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET;ORAL Prescription No AB 077166 MYLAN
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET;ORAL Prescription No AB 078627 SUN PHARM INDS INC
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET;ORAL Prescription No AB 076690 TEVA
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET;ORAL Prescription No AB 202036 YAOPHARMA CO LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET;ORAL Prescription No AB 077653 ZYDUS PHARMS USA

TABLET;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;ORAL Prescription No AB 078932 ALEMBIC PHARMS LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET;ORAL Prescription No AB 079098 AMNEAL PHARMS
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET;ORAL Prescription No AB 090555 AUROBINDO PHARMA
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET;ORAL Prescription No AB 206250 CADILA PHARMS LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET;ORAL Prescription No AB 078301 DR REDDYS LABS LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET;ORAL Prescription No AB 078554 HERITAGE PHARMS INC
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET;ORAL Prescription No AB 077166 MYLAN
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET;ORAL Prescription No AB 078627 SUN PHARM INDS INC
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET;ORAL Prescription No AB 076690 TEVA
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET;ORAL Prescription No AB 202036 YAOPHARMA CO LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET;ORAL Prescription No AB 077653 ZYDUS PHARMS USA

TABLET;ORAL; EQ 100MG 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 100MG BASE TABLET;ORAL Prescription No AB 078932 ALEMBIC PHARMS LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET;ORAL Prescription No AB 079098 AMNEAL PHARMS
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET;ORAL Prescription No AB 090555 AUROBINDO PHARMA
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET;ORAL Prescription No AB 206250 CADILA PHARMS LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET;ORAL Prescription No AB 078301 DR REDDYS LABS LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET;ORAL Prescription No AB 078554 HERITAGE PHARMS INC
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET;ORAL Prescription No AB 077166 MYLAN
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET;ORAL Prescription No AB 078627 SUN PHARM INDS INC
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET;ORAL Prescription No AB 076690 TEVA
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET;ORAL Prescription No AB 202036 YAOPHARMA CO LTD
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET;ORAL Prescription No AB 077653 ZYDUS PHARMS USA

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