Application 020711
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | ZYBAN | BUPROPION HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 100MG | No | No |
| 003 | ZYBAN | BUPROPION HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 150MG | Yes | No |
NDC Listings For This Application#
Documents#
| Document | Submission type | Date |
|---|---|---|
| 66743 | SUPPL | 2021-03-11 |
| 66742 | SUPPL | 2021-03-11 |
| 66711 | SUPPL | 2021-03-10 |
| 59397 | SUPPL | 2019-07-22 |
| 59396 | SUPPL | 2019-07-22 |
| 59394 | SUPPL | 2019-07-22 |
| 48294 | SUPPL | 2017-05-09 |
| 48293 | SUPPL | 2017-05-09 |
| 48292 | SUPPL | 2017-05-09 |
| 48251 | SUPPL | 2017-05-05 |
| 48250 | SUPPL | 2017-05-05 |
| 48249 | SUPPL | 2017-05-05 |
| 35204 | SUPPL | 2016-06-02 |
| 25610 | SUPPL | 2016-06-02 |
| 13273 | SUPPL | 2015-01-09 |
| 25608 | SUPPL | 2014-12-30 |
| 35203 | SUPPL | 2014-08-15 |
| 25609 | SUPPL | 2014-08-14 |
| 13272 | SUPPL | 2014-04-01 |
| 3173 | SUPPL | 2014-03-28 |
| 35202 | SUPPL | 2012-02-01 |
| 3172 | SUPPL | 2012-01-20 |
| 3171 | SUPPL | 2011-08-26 |
| 3167 | SUPPL | 2011-08-26 |
| 35200 | SUPPL | 2011-08-22 |
| 13271 | SUPPL | 2011-08-22 |
| 25606 | SUPPL | 2010-09-23 |
| 35201 | SUPPL | 2010-09-20 |
| 3170 | SUPPL | 2010-03-03 |
| 13270 | SUPPL | 2009-07-09 |
| 13269 | SUPPL | 2009-07-09 |
| 25607 | SUPPL | 2009-07-08 |
| 3169 | SUPPL | 2009-07-08 |
| 25605 | SUPPL | 2007-08-07 |
| 13268 | SUPPL | 2007-08-03 |
| 41605 | SUPPL | 2007-07-09 |
| 13267 | SUPPL | 2007-03-23 |
| 3168 | SUPPL | 2007-03-23 |
| 25604 | SUPPL | 2006-11-22 |
| 13266 | SUPPL | 2006-11-22 |
| 20870 | SUPPL | 2006-05-16 |
| 20869 | SUPPL | 2006-05-16 |
| 25603 | SUPPL | 2006-05-02 |
| 25602 | SUPPL | 2006-04-07 |
| 23594 | ORIG | 2005-07-28 |
| 13265 | SUPPL | 2005-01-13 |
| 3166 | SUPPL | 2005-01-13 |
| 35199 | SUPPL | 2004-11-08 |
| 25601 | SUPPL | 2004-11-08 |
| 13264 | SUPPL | 2004-11-08 |
| 3165 | SUPPL | 2004-11-08 |
| 35198 | SUPPL | 2004-07-01 |
| 35197 | SUPPL | 2004-07-01 |
| 35196 | SUPPL | 2004-07-01 |
| 25600 | SUPPL | 2004-07-01 |
| 25598 | SUPPL | 2004-07-01 |
| 13263 | SUPPL | 2004-07-01 |
| 3164 | SUPPL | 2004-07-01 |
| 3163 | SUPPL | 2004-07-01 |
| 20868 | ORIG | 2003-08-08 |
| 25599 | SUPPL | 2002-02-21 |
| 41604 | SUPPL | 2001-02-07 |
| 35195 | SUPPL | 2001-02-07 |
| 25597 | SUPPL | 2001-02-07 |