Application 020358
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | WELLBUTRIN SR | BUPROPION HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 50MG | No | No |
| 002 | WELLBUTRIN SR | BUPROPION HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 100MG | Yes | No |
| 003 | WELLBUTRIN SR | BUPROPION HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 150MG | Yes | No |
| 004 | WELLBUTRIN SR | BUPROPION HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 200MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0173-0135 | WELLBUTRIN | bupropion hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0135 | WELLBUTRIN | bupropion hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0135 | WELLBUTRIN | bupropion hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0135 | WELLBUTRIN | bupropion hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0135 | WELLBUTRIN | bupropion hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0135 | WELLBUTRIN | bupropion hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0135 | WELLBUTRIN | bupropion hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0135 | WELLBUTRIN | bupropion hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0135 | WELLBUTRIN | bupropion hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0722 | WELLBUTRIN | bupropion hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0722 | WELLBUTRIN | bupropion hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0722 | WELLBUTRIN | bupropion hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0722 | WELLBUTRIN | bupropion hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0722 | WELLBUTRIN | bupropion hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0722 | WELLBUTRIN | bupropion hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0722 | WELLBUTRIN | bupropion hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0722 | WELLBUTRIN | bupropion hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0722 | WELLBUTRIN | bupropion hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0947 | WELLBUTRIN | bupropion hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0947 | WELLBUTRIN | bupropion hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0947 | WELLBUTRIN | bupropion hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0947 | WELLBUTRIN | bupropion hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0947 | WELLBUTRIN | bupropion hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0947 | WELLBUTRIN | bupropion hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0947 | WELLBUTRIN | bupropion hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0947 | WELLBUTRIN | bupropion hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0947 | WELLBUTRIN | bupropion hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 70518-0639 | WELLBUTRIN | bupropion hydrochloride | REMEDYREPACK INC. | NDA | Current |
| 70518-0639 | WELLBUTRIN | bupropion hydrochloride | REMEDYREPACK INC. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84105 | SUPPL | 2025-11-06 |
| 84104 | SUPPL | 2025-11-06 |
| 84079 | SUPPL | 2025-11-06 |
| 78427 | SUPPL | 2024-05-08 |
| 78419 | SUPPL | 2024-05-07 |
| 72875 | SUPPL | 2022-12-13 |
| 72819 | SUPPL | 2022-12-07 |
| 65002 | SUPPL | 2020-10-23 |
| 65001 | SUPPL | 2020-10-23 |
| 64972 | SUPPL | 2020-10-22 |
| 60831 | SUPPL | 2019-11-13 |
| 60830 | SUPPL | 2019-11-13 |
| 60801 | SUPPL | 2019-11-08 |
| 49480 | SUPPL | 2017-08-21 |
| 49458 | SUPPL | 2017-08-18 |
| 48360 | SUPPL | 2017-05-12 |
| 48352 | SUPPL | 2017-05-10 |
| 48304 | SUPPL | 2017-05-09 |
| 48265 | SUPPL | 2017-05-08 |
| 34548 | SUPPL | 2016-04-27 |
| 24832 | SUPPL | 2016-04-27 |
| 24831 | SUPPL | 2014-12-17 |
| 12474 | SUPPL | 2014-12-17 |
| 12475 | SUPPL | 2014-07-22 |
| 2385 | SUPPL | 2014-07-21 |
| 41299 | SUPPL | 2014-07-07 |
| 20610 | SUPPL | 2014-07-07 |
| 24830 | SUPPL | 2013-12-26 |
| 2384 | SUPPL | 2013-12-26 |
| 34547 | SUPPL | 2013-12-24 |
| 12473 | SUPPL | 2013-12-24 |
| 34546 | SUPPL | 2013-03-26 |
| 2383 | SUPPL | 2013-03-21 |
| 2382 | SUPPL | 2012-08-03 |
| 41298 | SUPPL | 2012-06-26 |
| 41297 | SUPPL | 2011-12-09 |
| 41296 | SUPPL | 2011-12-09 |
| 41295 | SUPPL | 2011-12-09 |
| 20607 | SUPPL | 2011-12-09 |
| 24829 | SUPPL | 2011-07-28 |
| 34545 | SUPPL | 2011-07-25 |
| 34544 | SUPPL | 2011-05-23 |
| 34540 | SUPPL | 2011-05-23 |
| 24828 | SUPPL | 2011-05-19 |
| 2378 | SUPPL | 2011-05-19 |
| 34543 | SUPPL | 2010-05-28 |
| 24826 | SUPPL | 2010-05-27 |
| 2381 | SUPPL | 2010-03-03 |
| 24827 | SUPPL | 2009-07-07 |
| 2380 | SUPPL | 2009-07-07 |
| 12472 | SUPPL | 2009-07-06 |
| 12471 | SUPPL | 2009-07-06 |
| 24825 | SUPPL | 2007-08-07 |
| 12470 | SUPPL | 2007-08-03 |
| 20609 | SUPPL | 2007-06-29 |
| 20608 | SUPPL | 2007-04-09 |
| 34542 | SUPPL | 2007-02-02 |
| 24824 | SUPPL | 2007-02-02 |
| 2379 | SUPPL | 2006-07-13 |
| 2377 | SUPPL | 2006-07-13 |
| 34541 | SUPPL | 2006-07-05 |
| 34539 | SUPPL | 2006-07-05 |
| 2376 | SUPPL | 2006-03-03 |
| 23578 | ORIG | 2005-07-28 |
| 24823 | SUPPL | 2005-01-13 |
| 12469 | SUPPL | 2005-01-13 |
| 2375 | SUPPL | 2004-06-01 |
| 24822 | SUPPL | 2004-04-29 |
| 2374 | SUPPL | 2002-10-22 |
| 24819 | SUPPL | 2002-10-02 |
| 2372 | SUPPL | 2002-10-02 |
| 24821 | SUPPL | 2002-07-12 |
| 2373 | SUPPL | 2002-06-20 |
| 24820 | SUPPL | 2002-06-14 |
| 12468 | SUPPL | 2002-06-14 |
| 34538 | SUPPL | 2001-06-11 |
| 24818 | SUPPL | 2001-06-11 |
| 20606 | SUPPL | 2001-06-11 |
| 41294 | SUPPL | 1997-12-16 |
| 20605 | SUPPL | 1997-12-16 |