Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021410
Company: SB PHARMCO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AVANDAMET METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE 500MG;EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
AVANDAMET METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE 500MG;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
AVANDAMET METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE 500MG;EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
AVANDAMET METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE 1GM;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
AVANDAMET METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE 1GM;EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
10/10/2002 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21410lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21410ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021410_avandamet.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/05/2017 SUPPL-40 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021410s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021410s040ltr.pdf
12/16/2015 SUPPL-39 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-38 REMS-Assessment, REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021410s036s037s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021410Orig1s036,s037,s038ltr.pdf
05/07/2014 SUPPL-37 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021410s036s037s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021410Orig1s036,s037,s038ltr.pdf
05/07/2014 SUPPL-36 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021410s036s037s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021410Orig1s036,s037,s038ltr.pdf
09/16/2013 SUPPL-34 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
06/11/2013 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

01/25/2013 SUPPL-32 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-30 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021410s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021071s041,021410s030,021700s013ltr.pdf
11/13/2011 SUPPL-29 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021410s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021071s040,021410s029,021700s012ltr.pdf
05/18/2011 SUPPL-27 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021410s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021071s039,021410s027,021700s011ltr.pdf
02/03/2011 SUPPL-26 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
12/02/2008 SUPPL-25 REMS-Proposal, Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021410s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021410s025ltr.pdf
08/21/2007 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021410s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021410s023ltr.pdf
09/20/2007 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021410s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021410s022ltr.pdf
04/23/2007 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021410s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021410s019ltr.pdf
01/31/2007 SUPPL-16 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021410s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021410s016ltr.pdf
04/19/2006 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021410s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021410s013LTR.pdf
05/19/2006 SUPPL-10 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021410s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021410s010LTR.pdf
01/04/2005 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21410s009lbl.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%20Tabs.pdf
05/19/2004 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21071slr009,21410slr005,006_avandamet_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21071slr009,21410slr005,006ltr.pdf
05/19/2004 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21071slr009,21410slr005,006_avandamet_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21071slr009,21410slr005,006ltr.pdf
08/25/2003 SUPPL-1 Manufacturing (CMC)-Formulation Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21410scf001_avandamet_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21410scf001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/05/2017 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021410s040lbl.pdf
05/07/2014 SUPPL-38 REMS-Assessment Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021410s036s037s038lbl.pdf
05/07/2014 SUPPL-38 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021410s036s037s038lbl.pdf
05/07/2014 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021410s036s037s038lbl.pdf
05/07/2014 SUPPL-36 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021410s036s037s038lbl.pdf
05/30/2012 SUPPL-30 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021410s030lbl.pdf
11/13/2011 SUPPL-29 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021410s029lbl.pdf
05/18/2011 SUPPL-27 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021410s027lbl.pdf
02/03/2011 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021071s038,021410s026,021700s010lbl.pdf
12/02/2008 SUPPL-25 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021410s025lbl.pdf
12/02/2008 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021410s025lbl.pdf
09/20/2007 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021410s022lbl.pdf
08/21/2007 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021410s023lbl.pdf
04/23/2007 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021410s019lbl.pdf
01/31/2007 SUPPL-16 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021410s016lbl.pdf
05/19/2006 SUPPL-10 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021410s010lbl.pdf
04/19/2006 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021410s013lbl.pdf
01/04/2005 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21410s009lbl.pdf
05/19/2004 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21071slr009,21410slr005,006_avandamet_lbl.pdf
05/19/2004 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21071slr009,21410slr005,006_avandamet_lbl.pdf
08/25/2003 SUPPL-1 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21410scf001_avandamet_lbl.pdf
10/10/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21410lbl.pdf

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