Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 021071
Company: SB PHARMCO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AVANDIA ROSIGLITAZONE MALEATE EQ 2MG BASE TABLET;ORAL Prescription AB Yes No
AVANDIA ROSIGLITAZONE MALEATE EQ 4MG BASE TABLET;ORAL Prescription AB Yes No
AVANDIA ROSIGLITAZONE MALEATE EQ 8MG BASE TABLET;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
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
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-Modified, REMS-Assessment 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
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

AVANDIA

TABLET;ORAL; EQ 2MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AVANDIA ROSIGLITAZONE MALEATE EQ 2MG BASE TABLET;ORAL Prescription Yes AB 021071 SB PHARMCO
ROSIGLITAZONE MALEATE ROSIGLITAZONE MALEATE EQ 2MG BASE TABLET;ORAL Prescription No AB 076747 TEVA

TABLET;ORAL; EQ 4MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AVANDIA ROSIGLITAZONE MALEATE EQ 4MG BASE TABLET;ORAL Prescription Yes AB 021071 SB PHARMCO
ROSIGLITAZONE MALEATE ROSIGLITAZONE MALEATE EQ 4MG BASE TABLET;ORAL Prescription No AB 076747 TEVA

TABLET;ORAL; EQ 8MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AVANDIA ROSIGLITAZONE MALEATE EQ 8MG BASE TABLET;ORAL Prescription Yes AB 021071 SB PHARMCO
ROSIGLITAZONE MALEATE ROSIGLITAZONE MALEATE EQ 8MG BASE TABLET;ORAL Prescription No AB 076747 TEVA

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English