Application 022360
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE CONS
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | NICORETTE | NICOTINE POLACRILEX | TROCHE/LOZENGE;ORAL | EQ 2MG BASE | Yes | No |
| 002 | NICORETTE | NICOTINE POLACRILEX | TROCHE/LOZENGE;ORAL | EQ 4MG BASE | Yes | Yes |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0135-0508 | NICORETTE | nicotine polacrilex | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0135-0508 | NICORETTE | nicotine polacrilex | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0135-0508 | NICORETTE | nicotine polacrilex | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0135-0509 | NICORETTE | nicotine polacrilex | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0135-0509 | NICORETTE | nicotine polacrilex | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0135-0509 | NICORETTE | nicotine polacrilex | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0135-1500 | NICORETTE | nicotine polacrilex | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0135-2800 | NICORETTE | nicotine polacrilex | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 68151-5980 | NICORETTE | nicotine polacrilex | Carilion Materials Management | NDA | Current |