Application 021441
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ADVIL ALLERGY SINUS | CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | TABLET;ORAL | 2MG;200MG;30MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0573-0188 | ADVIL ALLERGY SINUS | chlorpheniramine maleate, ibuprofen, pseudoephedrine HCl | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0573-0188 | ADVIL ALLERGY SINUS | chlorpheniramine maleate, ibuprofen, pseudoephedrine HCl | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0573-0188 | ADVIL ALLERGY SINUS | chlorpheniramine maleate, ibuprofen, pseudoephedrine HCl | Wyeth Consumer Healthcare LLC | NDA | Current |
| 0573-0188 | ADVIL ALLERGY SINUS | chlorpheniramine maleate, ibuprofen, pseudoephedrine HCl | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 69424 | SUPPL | 2021-11-30 |
| 69406 | SUPPL | 2021-11-24 |
| 48058 | SUPPL | 2017-04-18 |
| 48048 | SUPPL | 2017-04-17 |
| 5384 | SUPPL | 2010-09-07 |
| 27789 | SUPPL | 2009-05-27 |
| 27788 | SUPPL | 2008-06-24 |
| 5383 | SUPPL | 2006-03-01 |
| 36935 | SUPPL | 2004-07-14 |
| 5382 | SUPPL | 2004-07-14 |
| 27787 | ORIG | 2004-05-26 |
| 42167 | ORIG | 2004-04-21 |
| 36934 | ORIG | 2003-04-09 |