Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021410
Company: SB PHARMCO
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ROSIGLITAZONE MALEATE | 500MG;EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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ROSIGLITAZONE MALEATE | 500MG;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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ROSIGLITAZONE MALEATE | 500MG;EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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ROSIGLITAZONE MALEATE | 1GM;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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ROSIGLITAZONE MALEATE | 1GM;EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 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-Modified, REMS-Assessment |
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 | Labeling, REMS-Proposal |
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-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021410s036s037s038lbl.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-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 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021410s025lbl.pdf | |
| 12/02/2008 | SUPPL-25 | REMS-Proposal | 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 |