Application 018612
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | NICORETTE | NICOTINE POLACRILEX | GUM, CHEWING;BUCCAL | EQ 2MG BASE | Yes | No |
| 003 | NICORETTE (MINT) | NICOTINE POLACRILEX | GUM, CHEWING;BUCCAL | EQ 2MG BASE | Yes | No |
| 004 | NICORETTE | NICOTINE POLACRILEX | GUM, CHEWING;BUCCAL | EQ 2MG BASE | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0135-0157 | Nicorette | nicotine polacrilex | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0135-0157 | Nicorette | nicotine polacrilex | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0135-0225 | Nicorette | nicotine polacrilex | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0135-0225 | Nicorette | nicotine polacrilex | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0135-0229 | Nicorette | nicotine polacrilex | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0135-0229 | Nicorette | nicotine polacrilex | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0135-0241 | Nicorette | nicotine polacrilex | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0135-0241 | Nicorette | nicotine polacrilex | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0135-0466 | Nicorette | nicotine polacrilex | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0135-0466 | Nicorette | nicotine polacrilex | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0135-0474 | Nicorette | nicotine polacrilex | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0135-0474 | Nicorette | nicotine polacrilex | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0135-0532 | Nicorette | nicotine polacrilex | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0135-0532 | Nicorette | nicotine polacrilex | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 11673-229 | NICOTINE POLACRILEX | nicotine polacrilex | Target Corporation | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 77184 | SUPPL | 2024-01-04 |
| 77179 | SUPPL | 2024-01-04 |
| 67476 | SUPPL | 2021-05-13 |
| 67183 | SUPPL | 2021-04-27 |
| 56535 | SUPPL | 2018-11-21 |
| 56485 | SUPPL | 2018-11-16 |
| 54650 | SUPPL | 2018-06-21 |
| 54550 | SUPPL | 2018-06-14 |
| 50747 | SUPPL | 2017-12-18 |
| 49988 | SUPPL | 2017-10-10 |
| 33523 | SUPPL | 2015-11-02 |
| 15047 | SUPPL | 2015-10-02 |
| 11248 | SUPPL | 2014-11-07 |
| 15046 | SUPPL | 2014-11-03 |
| 33522 | SUPPL | 2014-08-05 |
| 11247 | SUPPL | 2014-08-05 |
| 15045 | SUPPL | 2014-06-12 |
| 972 | SUPPL | 2014-06-12 |
| 33520 | SUPPL | 2014-01-16 |
| 33521 | SUPPL | 2013-11-07 |
| 15044 | SUPPL | 2013-10-31 |
| 971 | SUPPL | 2012-07-18 |
| 33519 | SUPPL | 2012-03-28 |
| 20133 | SUPPL | 2012-03-27 |
| 970 | SUPPL | 2012-02-17 |
| 969 | SUPPL | 2012-02-03 |
| 968 | SUPPL | 2011-09-29 |
| 967 | SUPPL | 2011-05-19 |
| 15043 | SUPPL | 2009-05-08 |
| 966 | SUPPL | 2008-06-16 |
| 20132 | SUPPL | 2007-07-06 |
| 15042 | SUPPL | 2007-07-05 |
| 33518 | SUPPL | 2007-06-27 |
| 965 | SUPPL | 2006-05-05 |
| 11246 | SUPPL | 2005-12-13 |
| 964 | SUPPL | 2005-12-13 |
| 20130 | SUPPL | 2005-05-02 |
| 15041 | SUPPL | 2004-06-24 |
| 963 | SUPPL | 2004-06-23 |
| 15040 | SUPPL | 2004-04-29 |
| 962 | SUPPL | 2002-08-09 |
| 33517 | SUPPL | 1998-12-23 |
| 20131 | SUPPL | 1998-12-23 |
| 961 | SUPPL | 1998-12-23 |