Application 021700
- Type
- NDA
- Sponsor
- SB PHARMCO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AVANDARYL | GLIMEPIRIDE; ROSIGLITAZONE MALEATE | TABLET;ORAL | 1MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | AVANDARYL | GLIMEPIRIDE; ROSIGLITAZONE MALEATE | TABLET;ORAL | 2MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | AVANDARYL | GLIMEPIRIDE; ROSIGLITAZONE MALEATE | TABLET;ORAL | 4MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 004 | AVANDARYL | GLIMEPIRIDE; ROSIGLITAZONE MALEATE | TABLET;ORAL | 2MG;8MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 005 | AVANDARYL | GLIMEPIRIDE; ROSIGLITAZONE MALEATE | TABLET;ORAL | 4MG;8MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 56230 | SUPPL | 2018-11-01 |
| 28411 | SUPPL | 2015-12-17 |
| 37487 | SUPPL | 2015-03-19 |
| 28410 | SUPPL | 2015-03-17 |
| 37486 | SUPPL | 2014-05-12 |
| 37485 | SUPPL | 2014-05-12 |
| 16225 | SUPPL | 2014-05-12 |
| 28409 | SUPPL | 2014-05-08 |
| 28408 | SUPPL | 2014-05-08 |
| 6019 | SUPPL | 2014-05-08 |
| 6018 | SUPPL | 2013-09-19 |
| 6017 | SUPPL | 2013-01-30 |
| 37484 | SUPPL | 2012-06-06 |
| 6016 | SUPPL | 2012-06-04 |
| 6015 | SUPPL | 2011-11-21 |
| 16224 | SUPPL | 2011-11-16 |
| 6014 | SUPPL | 2011-05-24 |
| 16223 | SUPPL | 2011-05-17 |
| 16222 | SUPPL | 2011-02-04 |
| 6013 | SUPPL | 2011-02-03 |
| 37483 | SUPPL | 2009-12-10 |
| 37482 | SUPPL | 2008-12-04 |
| 28407 | SUPPL | 2008-12-04 |
| 44144 | ORIG | 2008-02-21 |
| 28405 | SUPPL | 2007-09-25 |
| 37481 | SUPPL | 2007-08-22 |
| 28406 | SUPPL | 2007-08-22 |
| 42275 | ORIG | 2007-07-02 |
| 28404 | SUPPL | 2007-04-09 |
| 28403 | SUPPL | 2006-10-26 |
| 37480 | SUPPL | 2006-10-25 |
| 37479 | SUPPL | 2006-06-20 |
| 28402 | SUPPL | 2006-06-20 |
| 16221 | SUPPL | 2006-06-20 |
| 6012 | SUPPL | 2006-06-20 |
| 37478 | ORIG | 2005-11-30 |
| 6011 | ORIG | 2005-11-30 |