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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021700
Company: SB PHARMCO

Medication Guide

Other Important Information from FDA

Products on NDA 021700

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GLIMEPIRIDE; ROSIGLITAZONE MALEATE	1MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No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GLIMEPIRIDE; ROSIGLITAZONE MALEATE	2MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No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GLIMEPIRIDE; ROSIGLITAZONE MALEATE	4MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No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GLIMEPIRIDE; ROSIGLITAZONE MALEATE	2MG;8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No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GLIMEPIRIDE; ROSIGLITAZONE MALEATE	4MG;8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021700

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-Assessment, 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
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-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-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	Labeling, REMS-Proposal	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-Package Insert, Labeling-Container/Carton Labels	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

Labels for NDA 021700

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-Assessment	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021700s018s019s020lbl.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-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	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021700s008lbl.pdf
12/02/2008	SUPPL-8	REMS-Proposal	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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