Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020151
Company: WYETH PHARMS INC
Company: WYETH PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EFFEXOR | VENLAFAXINE HYDROCHLORIDE | EQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| EFFEXOR | VENLAFAXINE HYDROCHLORIDE | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| EFFEXOR | VENLAFAXINE HYDROCHLORIDE | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| EFFEXOR | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| EFFEXOR | VENLAFAXINE HYDROCHLORIDE | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| EFFEXOR | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 12/28/1993 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/12/2012 | SUPPL-60 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s031s055s058s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020151Orig1s031,s055,s058,s060ltr.pdf | |
| 05/02/2012 | SUPPL-59 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020151s059,020699s100ltr.pdf | |
| 12/12/2012 | SUPPL-58 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s031s055s058s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020151Orig1s031,s055,s058,s060ltr.pdf | |
| 01/06/2010 | SUPPL-57 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020151s056s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020151s056,s057,020699s090ltr.pdf | |
| 01/06/2010 | SUPPL-56 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020151s056s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020151s056,s057,020699s090ltr.pdf | |
| 12/12/2012 | SUPPL-55 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s031s055s058s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020151Orig1s031,s055,s058,s060ltr.pdf | |
| 01/30/2009 | SUPPL-54 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020151s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020699s087,020151s054ltr.pdf | |
| 11/09/2009 | SUPPL-53 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020151s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020151s053,020699s086ltr.pdf | |
| 02/11/2008 | SUPPL-52 | 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/2008/020151s052ltr.pdf | |
| 05/23/2008 | SUPPL-51 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020151s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020699s081, 020151s051ltr.pdf | |
| 02/07/2008 | SUPPL-50 | Labeling |
Label is not available on this site. |
||
| 09/20/2007 | SUPPL-49 | 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-47 | 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-46 | 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-45 | 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-44 | 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-43 | 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-41 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020151s041ltr.pdf |
| 01/12/2006 | SUPPL-39 | 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-38 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020151s038s039_020699s062s064ltr.pdf |
| 02/18/2005 | SUPPL-35 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20151s035,20699s058ltr.pdf |
| 02/24/2006 | SUPPL-34 | 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-33 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s033,020699s055lbl.pdf | |
| 05/13/2004 | SUPPL-32 | 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/2004/020151_S032_EFFEXOR_TABLETS.pdf | |
| 12/12/2012 | SUPPL-31 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s031s055s058s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020151Orig1s031,s055,s058,s060ltr.pdf | |
| 05/13/2004 | SUPPL-30 | 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/2004/020151_S030_EFFEXOR_TABLETS.pdf | |
| 04/08/2004 | SUPPL-29 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20151slr029,20699slr046ltr.pdf |
| 05/13/2004 | SUPPL-28 | 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/2004/020151_S028_EFFEXOR_TABLETS.pdf | |
| 03/19/2004 | SUPPL-27 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20151slr027,20699slr039,050ltr.pdf |
| 01/31/2003 | SUPPL-25 |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm | |
| 05/05/2004 | SUPPL-24 | 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 |
| 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 | |
| 01/31/2003 | SUPPL-22 |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm | |
| 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 | |
| 01/31/2003 | SUPPL-20 |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm | |
| 01/31/2003 | SUPPL-19 |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm | |
| 05/02/2001 | SUPPL-18 | 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-17 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20151s17s18lbl.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-16 |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020151s16s19s20s21s22s23s25,020699s14s18s21s23s26s27s34TOC.cfm | |
| 07/20/2000 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 03/03/2000 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 07/20/2000 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 10/04/1999 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/20/2000 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 12/09/1998 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 12/09/1998 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 12/09/1998 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 12/09/1998 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 06/25/1996 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 11/16/1994 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/28/1994 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 11/16/1994 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/12/2012 | SUPPL-60 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s031s055s058s060lbl.pdf | |
| 12/12/2012 | SUPPL-58 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s031s055s058s060lbl.pdf | |
| 12/12/2012 | SUPPL-55 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s031s055s058s060lbl.pdf | |
| 12/12/2012 | SUPPL-31 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s031s055s058s060lbl.pdf | |
| 05/02/2012 | SUPPL-59 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s059lbl.pdf | |
| 01/06/2010 | SUPPL-57 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020151s056s057lbl.pdf | |
| 01/06/2010 | SUPPL-56 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020151s056s057lbl.pdf | |
| 11/09/2009 | SUPPL-53 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020151s053lbl.pdf | |
| 01/30/2009 | SUPPL-54 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020151s054lbl.pdf | |
| 05/23/2008 | SUPPL-51 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020151s051lbl.pdf | |
| 02/11/2008 | SUPPL-52 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020151s052,020699s083lbl.pdf | |
| 09/20/2007 | SUPPL-49 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s047s049,020699s077s079lbl.pdf | |
| 09/20/2007 | SUPPL-47 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s047s049,020699s077s079lbl.pdf | |
| 08/01/2007 | SUPPL-46 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s046,020699s075lbl.pdf | |
| 08/01/2007 | SUPPL-33 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s033,020699s055lbl.pdf | |
| 02/07/2007 | SUPPL-43 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020151s043,020699s069lbl.pdf | |
| 10/20/2006 | SUPPL-45 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020151s045,020699s072lbl.pdf | |
| 09/14/2006 | SUPPL-44 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020151s044,020699s071lbl.pdf | |
| 05/13/2004 | SUPPL-32 | 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-30 | 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-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20151slr028,030,032,20699slr041,048,052_effexor_lbl.pdf | |
| 05/02/2001 | SUPPL-18 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20699s15lbl.pdf | |
| 05/02/2001 | SUPPL-17 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20151s17s18lbl.pdf |