Application 020941
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ABREVA | DOCOSANOL | CREAM;TOPICAL | 10% | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0135-0200 | ABREVA | docosanol | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0135-0200 | ABREVA | docosanol | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 50090-3476 | ABREVA | docosanol | A-S Medication Solutions | NDA | Current |
| 50090-3476 | ABREVA | docosanol | A-S Medication Solutions | NDA | Current |
| 50090-3476 | ABREVA | docosanol | A-S Medication Solutions | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85769 | SUPPL | 2026-04-27 |
| 85692 | SUPPL | 2026-04-20 |
| 46952 | SUPPL | 2017-01-24 |
| 46874 | SUPPL | 2017-01-18 |
| 13789 | SUPPL | 2015-02-17 |
| 26258 | SUPPL | 2015-02-02 |
| 3814 | SUPPL | 2008-02-14 |
| 35686 | SUPPL | 2007-05-29 |
| 3813 | SUPPL | 2007-05-29 |
| 21293 | ORIG | 2001-08-21 |
| 26257 | ORIG | 2000-07-25 |
| 13788 | ORIG | 2000-07-25 |