Application 021410
- Type
- NDA
- Sponsor
- SB PHARMCO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AVANDAMET | METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE | TABLET;ORAL | 500MG;EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | AVANDAMET | METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE | TABLET;ORAL | 500MG;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | AVANDAMET | METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE | TABLET;ORAL | 500MG;EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 004 | AVANDAMET | METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE | TABLET;ORAL | 1GM;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 005 | AVANDAMET | METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE | TABLET;ORAL | 1GM;EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 47950 | SUPPL | 2017-04-12 |
| 47932 | SUPPL | 2017-04-11 |
| 47929 | SUPPL | 2017-04-11 |
| 5289 | SUPPL | 2015-12-17 |
| 36850 | SUPPL | 2014-05-12 |
| 15397 | SUPPL | 2014-05-12 |
| 15396 | SUPPL | 2014-05-12 |
| 27701 | SUPPL | 2014-05-08 |
| 27700 | SUPPL | 2014-05-08 |
| 5288 | SUPPL | 2014-05-08 |
| 5287 | SUPPL | 2013-09-19 |
| 27699 | SUPPL | 2013-01-30 |
| 36849 | SUPPL | 2012-06-06 |
| 5286 | SUPPL | 2012-06-04 |
| 27698 | SUPPL | 2011-11-21 |
| 15395 | SUPPL | 2011-11-16 |
| 27697 | SUPPL | 2011-05-24 |
| 15394 | SUPPL | 2011-05-17 |
| 36848 | SUPPL | 2011-02-04 |
| 5285 | SUPPL | 2011-02-03 |
| 42141 | SUPPL | 2009-09-14 |
| 15393 | SUPPL | 2008-12-04 |
| 5284 | SUPPL | 2008-12-04 |
| 23655 | ORIG | 2008-02-21 |
| 15392 | SUPPL | 2007-09-26 |
| 27696 | SUPPL | 2007-09-25 |
| 36847 | SUPPL | 2007-08-22 |
| 5283 | SUPPL | 2007-08-22 |
| 5282 | SUPPL | 2007-05-01 |
| 36846 | SUPPL | 2007-04-25 |
| 27695 | SUPPL | 2007-02-12 |
| 15391 | SUPPL | 2007-02-02 |
| 36844 | SUPPL | 2006-05-22 |
| 5280 | SUPPL | 2006-05-22 |
| 5281 | SUPPL | 2006-04-21 |
| 36845 | SUPPL | 2006-04-20 |
| 5279 | SUPPL | 2005-03-01 |
| 36843 | SUPPL | 2005-01-11 |
| 36842 | SUPPL | 2004-05-27 |
| 15390 | SUPPL | 2004-05-27 |
| 27694 | SUPPL | 2004-05-26 |
| 5278 | SUPPL | 2004-05-26 |
| 15389 | SUPPL | 2003-08-28 |
| 5277 | SUPPL | 2003-08-28 |
| 42140 | ORIG | 2003-04-30 |
| 36841 | ORIG | 2002-10-10 |
| 27693 | ORIG | 2000-05-09 |