FDA Approval for HUMIRA issued to ABBVIE INC
$ABBV
Biotechnology: Pharmaceutical Preparations
Health Care
Biologic License Application (BLA): 125057
Company: ABBVIE INC
Company: ABBVIE INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HUMIRA | ADALIMUMAB | 40MG/0.8ML | SYRINGE | Prescription | None | No | No |
| HUMIRA | ADALIMUMAB | 40MG/0.8ML | VIAL | Prescription | None | 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 |
|---|---|---|---|---|---|---|---|
| 12/31/2002 | ORIG-1 | Approval | N/A; Orphan |
Label
Letter Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/adalabb123102LB.htm https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/adalabb123102L.htm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/125057_toc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/03/2023 | SUPPL-423 | Supplement |
Label is not available on this site. |
||
| 12/16/2020 | SUPPL-419 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125057s418s419lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125057Orig1s418, s419ltr.pdf | |
| 12/16/2020 | SUPPL-418 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125057s418s419lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125057Orig1s418, s419ltr.pdf | |
| 02/24/2021 | SUPPL-417 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125057s417lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125057Orig1s417ltr.pdf | |
| 03/11/2020 | SUPPL-415 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125057s415lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125057Orig1s415ltr.pdf | |
| 01/11/2019 | SUPPL-411 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125057Orig1s411lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125057Orig1s411ltr.pdf | |
| 12/06/2018 | SUPPL-410 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125057s410lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125057s410ltr.pdf | |
| 10/16/2018 | SUPPL-409 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125057s409lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125057Orig1s409ltr.pdf | |
| 09/28/2018 | SUPPL-408 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125057s408lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125057Orig1s408ltr.pdf | |
| 08/02/2018 | SUPPL-406 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125057s406lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125057Orig1s406ltr.pdf | |
| 12/14/2017 | SUPPL-403 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125057s403lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125057Orig1s403ltr.pdf | |
| 04/28/2017 | SUPPL-402 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125057s402lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125057Orig1s402ltr.pdf | |
| 04/21/2017 | SUPPL-401 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125057s401lbl.pdf | |
| 10/17/2016 | SUPPL-400 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125057s400lbl.pdf | |
| 03/27/2017 | SUPPL-399 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125057s399lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125057Orig1s399ltr.pdf | |
| 06/30/2016 | SUPPL-397 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125057s397lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125057Orig1s397ltr.pdf | |
| 11/23/2015 | SUPPL-394 | Supplement |
Label (PDF)
Letter (PDF) Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125057s394lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125057Orig1s394ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125057Orig1s394SumR.pdf | |
| 09/09/2015 | SUPPL-393 | Supplement |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125057Orig1s393ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/125057Orig1s393.pdf |
| 11/06/2014 | SUPPL-390 | Supplement |
Label is not available on this site. |
||
| 10/29/2014 | SUPPL-384 | Supplement |
Label is not available on this site. |
||
| 08/07/2014 | SUPPL-381 | Supplement |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/bla/2014/125057Orig1s381.pdf |
| 05/14/2014 | SUPPL-368 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125057s368lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125057Orig1s368ltr.pdf | |
| 09/30/2014 | SUPPL-367 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125057s367lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125057Orig1s367ltr.pdf | |
| 05/30/2014 | SUPPL-366 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125057s366lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125057Orig1s366ltr.pdf | |
| 09/23/2014 | SUPPL-356 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125057s356lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125057Orig1s356ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/125057Orig1s356.pdf | |
| 02/26/2014 | SUPPL-355 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125057Orig1s355lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125057Orig1s355_replace_ltr.pdf | |
| 09/19/2013 | SUPPL-327 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125057s327lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125057Orig1s327ltr.pdf | |
| 04/24/2013 | SUPPL-322 | Supplement |
Label (PDF)
Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125057s322lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125057Orig1s322.pdf | |
| 05/13/2013 | SUPPL-310 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125057s310lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125057Orig1s310ltr.pdf | |
| 12/24/2014 | SUPPL-280 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125057Orig1s280ltr.pdf |
| 05/24/2012 | SUPPL-278 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125057s0278lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125057s0278ltr.pdf | |
| 12/26/2011 | SUPPL-276 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125057s0276lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125057s276ltr.pdf | |
| 12/13/2011 | SUPPL-271 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125057s271ltr.pdf |
| 09/07/2011 | SUPPL-255 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125057s255ltr.pdf |
| 07/13/2011 | SUPPL-254 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125057s254ltr.pdf |
| 09/28/2012 | SUPPL-232 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125057s232lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125057Orig1s232ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125057Orig1s232.pdf | |
| 09/29/2010 | SUPPL-224 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125057s224ltr.pdf |
| 02/25/2011 | SUPPL-215 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125057s0215lbl.pdf | |
| 07/29/2010 | SUPPL-213 | Supplement |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125057s0213ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/bla/2010/125057Orig1s0213.pdf |
| 11/18/2010 | SUPPL-196 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125057s196lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125057s0196ltr.pdf | |
| 04/08/2010 | SUPPL-161 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125057s161ltr.pdf |
| 03/11/2009 | SUPPL-141 | Supplement |
Label is not available on this site. |
||
| 03/14/2011 | SUPPL-128 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125057s128ltr.pdf |
| 02/21/2008 | SUPPL-114 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125057s114lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125057s114ltr.pdf | |
| 01/18/2008 | SUPPL-110 | Supplement |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125057s0110lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125057s0110ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/125057s110TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/125057s110_SumR.pdf | |
| 09/05/2007 | SUPPL-108 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125057s108lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125057s108_ltr.pdf | |
| 11/09/2006 | SUPPL-95 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125057s071, s095LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125057s071, s095LTR.pdf | |
| 07/30/2007 | SUPPL-94 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125057s094_LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125057s094ltr.pdf | |
| 02/27/2007 | SUPPL-89 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125057s089Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125057s089Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/bla/2007/125057_S0089.pdf | |
| 11/09/2006 | SUPPL-71 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125057s071, s095LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125057s071, s095LTR.pdf | |
| 06/23/2006 | SUPPL-65 | Supplement |
Label is not available on this site. |
||
| 07/28/2006 | SUPPL-62 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125057s062lbl.pdf | |
| 02/16/2007 | SUPPL-60 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125057s060LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125057s060LTR.pdf | |
| 10/03/2005 | SUPPL-46 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125057s0045,0046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125057s0046ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/bla/2005/125057Orig1s046.pdf | |
| 10/03/2005 | SUPPL-45 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125057s0045,0046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125057s0045ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/bla/2005/125057Orig1s045.pdf | |
| 06/18/2004 | SUPPL-23 | Supplement |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/biologics/2004/125057_0023ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/125057Orig1s023.pdf |
| 07/30/2004 | SUPPL-16 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125057_0016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125057_0016ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/bla/2004/125057Orig1s016.pdf | |
| 09/12/2003 | SUPPL-4 | Supplement |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/24/2021 | SUPPL-417 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125057s417lbl.pdf | |
| 12/16/2020 | SUPPL-419 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125057s418s419lbl.pdf | |
| 12/16/2020 | SUPPL-418 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125057s418s419lbl.pdf | |
| 03/11/2020 | SUPPL-415 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125057s415lbl.pdf | |
| 01/11/2019 | SUPPL-411 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125057Orig1s411lbl.pdf | |
| 12/06/2018 | SUPPL-410 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125057s410lbl.pdf | |
| 10/16/2018 | SUPPL-409 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125057s409lbl.pdf | |
| 09/28/2018 | SUPPL-408 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125057s408lbl.pdf | |
| 08/02/2018 | SUPPL-406 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125057s406lbl.pdf | |
| 12/14/2017 | SUPPL-403 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125057s403lbl.pdf | |
| 04/28/2017 | SUPPL-402 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125057s402lbl.pdf |
| 04/21/2017 | SUPPL-401 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125057s401lbl.pdf | |
| 03/27/2017 | SUPPL-399 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125057s399lbl.pdf | |
| 10/17/2016 | SUPPL-400 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125057s400lbl.pdf |
| 06/30/2016 | SUPPL-397 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125057s397lbl.pdf | |
| 11/23/2015 | SUPPL-394 | Efficacy-Manufacturing Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125057s394lbl.pdf | |
| 09/30/2014 | SUPPL-367 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125057s367lbl.pdf | |
| 09/23/2014 | SUPPL-356 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125057s356lbl.pdf | |
| 05/30/2014 | SUPPL-366 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125057s366lbl.pdf | |
| 05/14/2014 | SUPPL-368 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125057s368lbl.pdf | |
| 02/26/2014 | SUPPL-355 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125057Orig1s355lbl.pdf | |
| 09/19/2013 | SUPPL-327 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125057s327lbl.pdf | |
| 05/13/2013 | SUPPL-310 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125057s310lbl.pdf | |
| 04/24/2013 | SUPPL-322 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125057s322lbl.pdf | |
| 09/28/2012 | SUPPL-232 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125057s232lbl.pdf | |
| 05/24/2012 | SUPPL-278 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125057s0278lbl.pdf | |
| 12/26/2011 | SUPPL-276 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125057s0276lbl.pdf | |
| 02/25/2011 | SUPPL-215 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125057s0215lbl.pdf | |
| 11/18/2010 | SUPPL-196 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125057s196lbl.pdf | |
| 02/21/2008 | SUPPL-114 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125057s114lbl.pdf | |
| 01/18/2008 | SUPPL-110 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125057s0110lbl.pdf | |
| 09/05/2007 | SUPPL-108 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125057s108lbl.pdf | |
| 07/30/2007 | SUPPL-94 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125057s094_LBL.pdf | |
| 02/27/2007 | SUPPL-89 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125057s089Lbl.pdf | |
| 02/16/2007 | SUPPL-60 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125057s060LBL.pdf | |
| 11/09/2006 | SUPPL-95 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125057s071, s095LBL.pdf | |
| 11/09/2006 | SUPPL-71 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125057s071, s095LBL.pdf | |
| 07/28/2006 | SUPPL-62 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125057s062lbl.pdf | |
| 10/03/2005 | SUPPL-46 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125057s0045,0046lbl.pdf | |
| 10/03/2005 | SUPPL-45 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125057s0045,0046lbl.pdf | |
| 07/30/2004 | SUPPL-16 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125057_0016lbl.pdf | |
| 12/31/2002 | ORIG-1 | Approval | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/adalabb123102LB.htm |