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ROSIGLITAZONE MALEATE | 500MG;EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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ROSIGLITAZONE MALEATE | 500MG;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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ROSIGLITAZONE MALEATE | 500MG;EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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ROSIGLITAZONE MALEATE | 1GM;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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ROSIGLITAZONE MALEATE | 1GM;EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| 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 |