Application 018644
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | WELLBUTRIN | BUPROPION HYDROCHLORIDE | TABLET;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | WELLBUTRIN | BUPROPION HYDROCHLORIDE | TABLET;ORAL | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | WELLBUTRIN | BUPROPION HYDROCHLORIDE | TABLET;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84107 | SUPPL | 2025-11-06 |
| 84106 | SUPPL | 2025-11-06 |
| 84078 | SUPPL | 2025-11-06 |
| 82435 | SUPPL | 2025-06-03 |
| 81111 | SUPPL | 2025-02-06 |
| 78429 | SUPPL | 2024-05-08 |
| 78418 | SUPPL | 2024-05-07 |
| 72827 | SUPPL | 2022-12-08 |
| 72826 | SUPPL | 2022-12-08 |
| 72818 | SUPPL | 2022-12-07 |
| 65004 | SUPPL | 2020-10-23 |
| 65003 | SUPPL | 2020-10-23 |
| 64971 | SUPPL | 2020-10-22 |
| 60829 | SUPPL | 2019-11-13 |
| 60828 | SUPPL | 2019-11-13 |
| 60800 | SUPPL | 2019-11-08 |
| 49479 | SUPPL | 2017-08-21 |
| 49456 | SUPPL | 2017-08-18 |
| 48359 | SUPPL | 2017-05-12 |
| 48354 | SUPPL | 2017-05-10 |
| 48303 | SUPPL | 2017-05-09 |
| 48263 | SUPPL | 2017-05-08 |
| 33536 | SUPPL | 2016-04-27 |
| 15066 | SUPPL | 2016-04-27 |
| 33534 | SUPPL | 2014-12-17 |
| 988 | SUPPL | 2014-12-17 |
| 33535 | SUPPL | 2014-07-22 |
| 15065 | SUPPL | 2014-07-21 |
| 20140 | SUPPL | 2014-07-07 |
| 20139 | SUPPL | 2014-07-07 |
| 15064 | SUPPL | 2013-12-26 |
| 987 | SUPPL | 2013-12-26 |
| 33533 | SUPPL | 2013-12-24 |
| 11257 | SUPPL | 2013-12-24 |
| 33532 | SUPPL | 2013-03-26 |
| 986 | SUPPL | 2013-03-21 |
| 15063 | SUPPL | 2012-08-03 |
| 40814 | SUPPL | 2012-06-26 |
| 15062 | SUPPL | 2011-07-28 |
| 11256 | SUPPL | 2011-07-25 |
| 33531 | SUPPL | 2011-05-23 |
| 15061 | SUPPL | 2011-05-19 |
| 11254 | SUPPL | 2010-05-28 |
| 15058 | SUPPL | 2010-05-27 |
| 15060 | SUPPL | 2010-03-03 |
| 15059 | SUPPL | 2009-07-07 |
| 985 | SUPPL | 2009-07-07 |
| 33530 | SUPPL | 2009-07-06 |
| 11255 | SUPPL | 2009-07-06 |
| 15057 | SUPPL | 2007-08-07 |
| 33529 | SUPPL | 2007-08-03 |
| 40813 | SUPPL | 2007-06-29 |
| 984 | SUPPL | 2007-02-02 |
| 983 | SUPPL | 2006-07-13 |
| 982 | SUPPL | 2006-07-13 |
| 33528 | SUPPL | 2006-07-05 |
| 11253 | SUPPL | 2006-07-05 |
| 15056 | SUPPL | 2006-03-03 |
| 44024 | ORIG | 2005-07-28 |
| 11252 | SUPPL | 2005-01-13 |
| 981 | SUPPL | 2005-01-13 |
| 980 | SUPPL | 2004-06-01 |
| 40812 | SUPPL | 2003-06-17 |
| 40811 | SUPPL | 2003-06-17 |
| 20138 | SUPPL | 2003-06-17 |
| 15055 | SUPPL | 2002-10-22 |
| 15053 | SUPPL | 2002-10-02 |
| 979 | SUPPL | 2002-10-02 |
| 15052 | SUPPL | 2002-06-20 |
| 15054 | SUPPL | 2002-02-12 |
| 57442 | ORIG | 1985-12-30 |