Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021700
Company: SB PHARMCO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AVANDARYL GLIMEPIRIDE; ROSIGLITAZONE MALEATE 1MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
AVANDARYL GLIMEPIRIDE; ROSIGLITAZONE MALEATE 2MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
AVANDARYL GLIMEPIRIDE; ROSIGLITAZONE MALEATE 4MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
AVANDARYL GLIMEPIRIDE; ROSIGLITAZONE MALEATE 2MG;8MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
AVANDARYL GLIMEPIRIDE; ROSIGLITAZONE MALEATE 4MG;8MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
11/23/2005 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021700lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021700ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021700s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/16/2015 SUPPL-22 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021071Orig1s050,021410Orig1s039,021700Orig1s022ltr.pdf
03/16/2015 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021700s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021700Orig1s021ltr.pdf
05/07/2014 SUPPL-20 REMS-Modified, REMS-Assessment Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021700s018s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021700Orig1s018,s019,s020ltr.pdf
05/07/2014 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021700s018s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021700Orig1s018,s019,s020ltr.pdf
05/07/2014 SUPPL-18 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021700s018s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021700Orig1s018,s019,s020ltr.pdf
09/16/2013 SUPPL-16 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-15 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-13 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021700s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021071s041,021410s030,021700s013ltr.pdf
11/13/2011 SUPPL-12 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021700s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021071s040,021410s029,021700s012ltr.pdf
05/18/2011 SUPPL-11 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021700s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021071s039,021410s027,021700s011ltr.pdf
02/03/2011 SUPPL-10 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
11/29/2009 SUPPL-9 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021700s009lbl.pdf
12/02/2008 SUPPL-8 REMS-Proposal, Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021700s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021700s008ltr.pdf
08/21/2007 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021700s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021700s007ltr.pdf
09/20/2007 SUPPL-6 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021700s006ltr.pdf
03/30/2007 SUPPL-5 Labeling-Container/Carton Labels, Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021700s005ltr.pdf
06/15/2006 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021700s002s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021700s002,217s004LTR.pdf
10/24/2006 SUPPL-3 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021700s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021700s003ltr.pdf
06/15/2006 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021700s002s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021700s002,217s004LTR.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/16/2015 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021700s021lbl.pdf
05/07/2014 SUPPL-20 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021700s018s019s020lbl.pdf
05/07/2014 SUPPL-20 REMS-Assessment Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021700s018s019s020lbl.pdf
05/07/2014 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021700s018s019s020lbl.pdf
05/07/2014 SUPPL-18 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021700s018s019s020lbl.pdf
05/30/2012 SUPPL-13 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021700s013lbl.pdf
11/13/2011 SUPPL-12 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021700s012lbl.pdf
05/18/2011 SUPPL-11 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021700s011lbl.pdf
02/03/2011 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021071s038,021410s026,021700s010lbl.pdf
11/29/2009 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021700s009lbl.pdf
12/02/2008 SUPPL-8 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021700s008lbl.pdf
12/02/2008 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021700s008lbl.pdf
08/21/2007 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021700s007lbl.pdf
10/24/2006 SUPPL-3 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021700s003lbl.pdf
06/15/2006 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021700s002s004lbl.pdf
06/15/2006 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021700s002s004lbl.pdf
11/23/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021700lbl.pdf

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