Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020699
Company: UPJOHN
Company: UPJOHN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EFFEXOR XR | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| EFFEXOR XR | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| EFFEXOR XR | VENLAFAXINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| EFFEXOR XR | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/20/1997 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020699_effexorxr_toc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/18/2023 | SUPPL-118 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020699s118lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020699Orig1s118ltr.pdf | |
| 09/20/2021 | SUPPL-114 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020699s114lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020699Orig1s114ltr.pdf | |
| 11/10/2021 | SUPPL-113 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020699s113lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020699Orig1s113ltr.pdf | |
| 08/15/2022 | SUPPL-112 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020699s112lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020699Orig1s112ltr.pdf | |
| 12/19/2017 | SUPPL-111 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020699s110s111lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020699Orig1s110s111ltr.pdf | |
| 12/19/2017 | SUPPL-110 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020699s110s111lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020699Orig1s110s111ltr.pdf | |
| 03/29/2017 | SUPPL-108 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020699s108lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020699Orig1s108ltr.pdf | |
| 01/04/2017 | SUPPL-107 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020699s107lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021992Orig1s044,020699Orig1s107ltr.pdf | |
| 02/29/2016 | SUPPL-106 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020699s106lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020699Orig1s106ltr.pdf | |
| 07/07/2014 | SUPPL-105 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020699s103s105lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020699Orig1s103,s105ltr.pdf | |
| 10/21/2014 | SUPPL-104 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020699Orig1s104ltr.pdf |
| 07/07/2014 | SUPPL-103 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020699s103s105lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020699Orig1s103,s105ltr.pdf | |
| 12/18/2012 | SUPPL-102 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020699s099,s102lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020699Orig1s099,s102ltr.pdf | |
| 05/03/2012 | SUPPL-100 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s059,020699s100lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020151s059,020699s100ltr.pdf | |
| 12/18/2012 | SUPPL-99 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020699s099,s102lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020699Orig1s099,s102ltr.pdf | |
| 12/17/2014 | SUPPL-91 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020699s091lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020699Orig1s091ltr.pdf | |
| 01/06/2010 | SUPPL-90 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020699s090lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020151s056,s057,020699s090ltr.pdf | |
| 08/24/2012 | SUPPL-89 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020699s049-89.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020699Orig1s049,s089ltr.pdf | |
| 01/30/2009 | SUPPL-87 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020699s087lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020699s087,020151s054ltr.pdf | |
| 11/09/2009 | SUPPL-86 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020699s086lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020151s053,020699s086ltr.pdf | |
| 02/11/2008 | SUPPL-83 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020151s052,020699s083lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020699s083ltr.pdf | |
| 05/23/2008 | SUPPL-81 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020699s081lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020699s081, 020151s051ltr.pdf | |
| 02/07/2008 | SUPPL-80 | Labeling |
Label is not available on this site. |
||
| 09/20/2007 | SUPPL-79 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s047s049,020699s077s079lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020151s047,s49,020699s77,s79ltr.pdf | |
| 09/20/2007 | SUPPL-77 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s047s049,020699s077s079lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020151s047,s49,020699s77,s79ltr.pdf | |
| 08/01/2007 | SUPPL-75 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s046,020699s075lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020151s046, 020699s075LTR.pdf | |
| 10/20/2006 | SUPPL-72 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020151s045,020699s072lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020151s045, 020699s072ltr.pdf | |
| 09/14/2006 | SUPPL-71 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020151s044,020699s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020151s044, 020699s071ltr.pdf | |
| 02/07/2007 | SUPPL-69 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s043,020699s069lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020151s043, 020699s069ltr.pdf | |
| 01/30/2008 | SUPPL-67 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020699s067ltr.pdf |
| 03/02/2006 | SUPPL-66 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020699s066ltr.pdf |
| 01/12/2006 | SUPPL-64 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020151s038s039_020699s062s064ltr.pdf |
| 01/12/2006 | SUPPL-62 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020151s038s039_020699s062s064ltr.pdf |
| 12/01/2005 | SUPPL-59 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020699s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020699s059ltr.pdf | |
| 02/18/2005 | SUPPL-58 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20151s035,20699s058ltr.pdf |
| 11/18/2005 | SUPPL-57 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020699s054,057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020699s054,057ltr.pdf | |
| 02/24/2006 | SUPPL-56 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020151s034,020699s056ltr.pdf |
| 08/01/2007 | SUPPL-55 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s033,020699s055lbl.pdf | |
| 11/18/2005 | SUPPL-54 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020699s054,057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020699s054,057ltr.pdf | |
| 05/13/2004 | SUPPL-52 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20151slr028,030,032,20699slr041,048,052_effexor_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20151slr028,030,032,20699slr041,048,052ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020699_S052_EFFEXOR_TABLETS.pdf | |
| 03/19/2004 | SUPPL-50 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20151slr027,20699slr039,050ltr.pdf |
| 08/24/2012 | SUPPL-49 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020699s049-89.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020699Orig1s049,s089ltr.pdf | |
| 05/13/2004 | SUPPL-48 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20151slr028,030,032,20699slr041,048,052_effexor_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20151slr028,030,032,20699slr041,048,052ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020699_S048_EFFEXOR_TABLETS.pdf | |
| 12/14/2007 | SUPPL-47 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020699s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020699s047ltr.pdf | |
| 04/08/2004 | SUPPL-46 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20151slr029,20699slr046ltr.pdf |
| 03/16/2004 | SUPPL-45 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20699slr045ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020699_s045_EFFEXOR_XR_EXTENDED_RELEASE_CAPS.pdf |
| 09/02/2003 | SUPPL-43 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20699slr038,043ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020699_S043_EFFEXOR_AP.pdf |
| 05/13/2004 | SUPPL-41 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20151slr028,030,032,20699slr041,048,052_effexor_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20151slr028,030,032,20699slr041,048,052ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020699_S041_EFFEXOR_TABLETS.pdf | |
| 03/19/2004 | SUPPL-39 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20151slr027,20699slr039,050ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020699_s039_EFFEXOR XR_EXTENDED_RELEASE_CAPS.pdf |
| 09/02/2003 | SUPPL-38 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20699slr038,043ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020699_S038_EFFEXOR_AP.pdf |
| 01/31/2003 | SUPPL-34 | Labeling |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm |
| 02/26/2003 | SUPPL-32 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20699slr032ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020699_S032_EFFEXOR_AP.pdf |
| 05/05/2004 | SUPPL-30 | Efficacy-New Patient Population |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20151se5-024,20699se5-030ltr.pdf |
| 10/22/2002 | SUPPL-29 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20699slr029ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020699_S029_EFFEXOR_AP.pdf |
| 11/19/2002 | SUPPL-28 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020699_S028_EFFEXOR.pdf |
| 01/31/2003 | SUPPL-27 |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm | |
| 01/31/2003 | SUPPL-26 |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm | |
| 08/07/2002 | SUPPL-25 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020699_S025_EFFEXOR_XR.pdf |
| 10/23/2001 | SUPPL-24 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020699_s024_EFFEXOR XR_EXTENDED_RELEASE_CAPS.pdf |
| 01/31/2003 | SUPPL-23 |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm | |
| 02/11/2003 | SUPPL-22 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020699s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20699se1-022ltr.pdf | |
| 01/31/2003 | SUPPL-21 |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm | |
| 12/13/2000 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/31/2003 | SUPPL-18 |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm | |
| 10/31/2000 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/02/2001 | SUPPL-16 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20699s15lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20699S15ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020151s017s018,020699s015s016EffexorTOC.cfm | |
| 05/02/2001 | SUPPL-15 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20699s15lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20699S15ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020151s017s018,020699s015s016EffexorTOC.cfm | |
| 01/31/2003 | SUPPL-14 |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm | |
| 07/20/2000 | SUPPL-13 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020699_s013_EFFEXOR_XR.pdf |
| 06/12/2000 | SUPPL-12 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020699_S012_EFFEXOR_XR.pdf |
| 02/25/2000 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/09/2000 | SUPPL-10 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020699_S010_EFFEXOR.pdf |
| 03/09/2000 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/03/2000 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 07/13/2000 | SUPPL-7 | Efficacy-Labeling Change With Clinical Data |
Label is not available on this site. |
||
| 12/21/1999 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/22/2001 | SUPPL-5 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020699_s005_EFFEXOR XR_EXTENDED_RELEASE_CAPS.pdf |
| 05/08/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/1999 | SUPPL-1 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20699s1lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20699s1ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/18/2023 | SUPPL-118 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020699s118lbl.pdf | |
| 08/15/2022 | SUPPL-112 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020699s112lbl.pdf | |
| 11/10/2021 | SUPPL-113 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020699s113lbl.pdf | |
| 09/20/2021 | SUPPL-114 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020699s114lbl.pdf | |
| 09/20/2021 | SUPPL-114 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020699s114lbl.pdf | |
| 12/19/2017 | SUPPL-111 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020699s110s111lbl.pdf | |
| 12/19/2017 | SUPPL-110 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020699s110s111lbl.pdf | |
| 03/29/2017 | SUPPL-108 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020699s108lbl.pdf | |
| 01/04/2017 | SUPPL-107 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020699s107lbl.pdf | |
| 01/04/2017 | SUPPL-107 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020699s107lbl.pdf | |
| 02/29/2016 | SUPPL-106 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020699s106lbl.pdf | |
| 12/17/2014 | SUPPL-91 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020699s091lbl.pdf | |
| 07/07/2014 | SUPPL-105 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020699s103s105lbl.pdf | |
| 07/07/2014 | SUPPL-103 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020699s103s105lbl.pdf | |
| 12/18/2012 | SUPPL-102 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020699s099,s102lbl.pdf | |
| 12/18/2012 | SUPPL-99 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020699s099,s102lbl.pdf | |
| 08/24/2012 | SUPPL-89 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020699s049-89.pdf | |
| 08/24/2012 | SUPPL-49 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020699s049-89.pdf | |
| 05/03/2012 | SUPPL-100 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s059,020699s100lbl.pdf | |
| 01/06/2010 | SUPPL-90 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020699s090lbl.pdf | |
| 11/09/2009 | SUPPL-86 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020699s086lbl.pdf | |
| 01/30/2009 | SUPPL-87 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020699s087lbl.pdf | |
| 05/23/2008 | SUPPL-81 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020699s081lbl.pdf | |
| 02/11/2008 | SUPPL-83 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020151s052,020699s083lbl.pdf | |
| 12/14/2007 | SUPPL-47 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020699s047lbl.pdf | |
| 09/20/2007 | SUPPL-79 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s047s049,020699s077s079lbl.pdf | |
| 09/20/2007 | SUPPL-77 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s047s049,020699s077s079lbl.pdf | |
| 08/01/2007 | SUPPL-75 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s046,020699s075lbl.pdf | |
| 08/01/2007 | SUPPL-55 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s033,020699s055lbl.pdf | |
| 02/07/2007 | SUPPL-69 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s043,020699s069lbl.pdf | |
| 10/20/2006 | SUPPL-72 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020151s045,020699s072lbl.pdf | |
| 09/14/2006 | SUPPL-71 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020151s044,020699s071lbl.pdf | |
| 12/01/2005 | SUPPL-59 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020699s059lbl.pdf | |
| 11/18/2005 | SUPPL-57 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020699s054,057lbl.pdf | |
| 11/18/2005 | SUPPL-54 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020699s054,057lbl.pdf | |
| 05/13/2004 | SUPPL-52 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20151slr028,030,032,20699slr041,048,052_effexor_lbl.pdf | |
| 05/13/2004 | SUPPL-48 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20151slr028,030,032,20699slr041,048,052_effexor_lbl.pdf | |
| 05/13/2004 | SUPPL-41 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20151slr028,030,032,20699slr041,048,052_effexor_lbl.pdf | |
| 02/11/2003 | SUPPL-22 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020699s022lbl.pdf | |
| 05/02/2001 | SUPPL-16 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20699s15lbl.pdf | |
| 05/02/2001 | SUPPL-15 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20699s15lbl.pdf | |
| 03/11/1999 | SUPPL-1 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20699s1lbl.pdf |
EFFEXOR XR
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 | UPJOHN |
| 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 | 217390 | GRANULES |
| 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 | 203332 | INVENTIA HLTHCARE |
| 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 | 200430 | NOSTRUM PHARMS LLC |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091123 | ORBION PHARMS |
| 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 | 090071 | VALEANT PHARMS NORTH |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078865 | WOCKHARDT BIO AG |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214654 | YICHANG HUMANWELL |
| 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 | UPJOHN |
| 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 | 217390 | GRANULES |
| 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 | 203332 | INVENTIA HLTHCARE |
| 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 | 200430 | NOSTRUM PHARMS LLC |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091123 | ORBION PHARMS |
| 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 | 090071 | VALEANT PHARMS NORTH |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078865 | WOCKHARDT BIO AG |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214654 | YICHANG HUMANWELL |
| 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 | UPJOHN |
| 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 | 217390 | GRANULES |
| 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 | 203332 | INVENTIA HLTHCARE |
| 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 | 200430 | NOSTRUM PHARMS LLC |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091123 | ORBION PHARMS |
| 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 | 090071 | VALEANT PHARMS NORTH |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078865 | WOCKHARDT BIO AG |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214654 | YICHANG HUMANWELL |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090174 | ZYDUS PHARMS USA INC |