Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021071
Company: WOODWARD
Company: WOODWARD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AVANDIA | ROSIGLITAZONE MALEATE | EQ 2MG BASE | TABLET;ORAL | Discontinued | None | Yes | No |
| AVANDIA | ROSIGLITAZONE MALEATE | EQ 4MG BASE | TABLET;ORAL | Discontinued | None | Yes | No |
| AVANDIA | ROSIGLITAZONE MALEATE | EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 05/25/1999 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21071ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21071_Avandia.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/05/2019 | SUPPL-52 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021071s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021071Orig1s052ltr.pdf | |
| 09/19/2016 | SUPPL-51 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021071s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021071Orig1s051ltr.pdf | |
| 12/16/2015 | SUPPL-50 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021071Orig1s050,021410Orig1s039,021700Orig1s022ltr.pdf |
| 05/07/2014 | SUPPL-49 | REMS-Assessment, REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021071s047s048s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021071Orig1s047,s048,s049ltr.pdf | |
| 05/07/2014 | SUPPL-48 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021071s047s048s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021071Orig1s047,s048,s049ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021071Orig1s048.pdf | |
| 05/07/2014 | SUPPL-47 | REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021071s047s048s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021071Orig1s047,s048,s049ltr.pdf | |
| 09/16/2013 | SUPPL-45 | REMS-Assessment, REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021071Orig1s045,021410Orig1s034,021700Orig1s016ltr.pdf |
| 01/25/2013 | SUPPL-44 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021071Orig1s044,021410Orig1s032,021700Orig1s015ltr.pdf |
| 05/30/2012 | SUPPL-41 | REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021071s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021071s041,021410s030,021700s013ltr.pdf | |
| 11/13/2011 | SUPPL-40 | REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021071s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021071s040,021410s029,021700s012ltr.pdf | |
| 05/18/2011 | SUPPL-39 | REMS-Proposal |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021071s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021071s039,021410s027,021700s011ltr.pdf | |
| 02/03/2011 | SUPPL-38 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021071s038,021410s026,021700s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021071s038,021410s026,021700s010ltr.pdf | |
| 10/20/2008 | SUPPL-34 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021071s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021071s034ltr.pdf | |
| 02/22/2008 | SUPPL-32 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021071s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021071s032ltr.pdf | |
| 11/14/2007 | SUPPL-31 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021071s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021071s031ltr.pdf | |
| 01/16/2008 | SUPPL-29 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021071s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021071s029ltr.pdf | |
| 08/14/2007 | SUPPL-28 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021071s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021071s028LTR.pdf | |
| 09/20/2007 | SUPPL-27 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021071s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021071s027ltr.pdf | |
| 07/10/2008 | SUPPL-26 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021071s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021071s026ltr.pdf | |
| 06/25/2007 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 04/23/2007 | SUPPL-23 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021071s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021071s023ltr.pdf | |
| 06/16/2006 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021071s019s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021071s019, 021071s021LTR.pdf | |
| 06/16/2006 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021071s019s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021071s019, 021071s021LTR.pdf | |
| 04/21/2006 | SUPPL-16 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021071s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021071s016LTR.pdf | |
| 07/29/2005 | SUPPL-15 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021071s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021071s015ltr.pdf | |
| 01/04/2005 | SUPPL-14 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21071s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21071s014,21410s009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021071_s014_Avandia Tabs.pdf | |
| 02/28/2005 | SUPPL-12 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21071s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21071s012ltr.pdf | |
| 05/12/2005 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021071s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021071s010ltr.pdf | |
| 05/19/2004 | SUPPL-9 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21071slr009,21410slr005,006ltr.pdf |
| 12/03/2002 | SUPPL-8 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21071slr008ltr.pdf |
| 12/13/2000 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/08/2001 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 12/05/2000 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 02/27/2003 | SUPPL-4 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021071s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21071se1-004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021071_S004_AVANDIA.pdf | |
| 07/03/2000 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/11/2000 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 04/03/2000 | SUPPL-1 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-071S001_Avandia_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21071S1LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-071S001_Avandia.cfm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/05/2019 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021071s052lbl.pdf | |
| 09/19/2016 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021071s051lbl.pdf | |
| 05/07/2014 | SUPPL-49 | REMS-Assessment | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021071s047s048s049lbl.pdf | |
| 05/07/2014 | SUPPL-49 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021071s047s048s049lbl.pdf | |
| 05/07/2014 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021071s047s048s049lbl.pdf | |
| 05/07/2014 | SUPPL-47 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021071s047s048s049lbl.pdf | |
| 05/30/2012 | SUPPL-41 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021071s041lbl.pdf | |
| 11/13/2011 | SUPPL-40 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021071s040lbl.pdf | |
| 05/18/2011 | SUPPL-39 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021071s039lbl.pdf | |
| 02/03/2011 | SUPPL-38 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021071s038,021410s026,021700s010lbl.pdf | |
| 10/20/2008 | SUPPL-34 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021071s034lbl.pdf | |
| 07/10/2008 | SUPPL-26 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021071s026lbl.pdf | |
| 02/22/2008 | SUPPL-32 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021071s032lbl.pdf | |
| 01/16/2008 | SUPPL-29 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021071s029lbl.pdf | |
| 11/14/2007 | SUPPL-31 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021071s031lbl.pdf | |
| 09/20/2007 | SUPPL-27 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021071s027lbl.pdf | |
| 08/14/2007 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021071s028lbl.pdf | |
| 04/23/2007 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021071s023lbl.pdf | |
| 06/16/2006 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021071s019s021lbl.pdf | |
| 06/16/2006 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021071s019s021lbl.pdf | |
| 04/21/2006 | SUPPL-16 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021071s016lbl.pdf | |
| 07/29/2005 | SUPPL-15 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021071s015lbl.pdf | |
| 05/12/2005 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021071s010lbl.pdf | |
| 02/28/2005 | SUPPL-12 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21071s012lbl.pdf | |
| 01/04/2005 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21071s014lbl.pdf | |
| 02/27/2003 | SUPPL-4 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021071s004lbl.pdf | |
| 04/03/2000 | SUPPL-1 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-071S001_Avandia_prntlbl.pdf | |
| 05/25/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21071lbl.pdf |