Application 020723
- Type
- NDA
- Sponsor
- BAUSCH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ALDARA | IMIQUIMOD | CREAM;TOPICAL | 5% | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 99207-260 | Aldara | imiquimod | Valeant Pharmaceuticals North America LLC | NDA | Current |
| 99207-260 | Aldara | imiquimod | Bausch Health US LLC | NDA | Current |
| 99207-260 | Aldara | imiquimod | Bausch Health US LLC | NDA | Current |
| 99207-260 | Aldara | imiquimod | Bausch Health US LLC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 79746 | SUPPL | 2024-09-26 |
| 79743 | SUPPL | 2024-09-26 |
| 20881 | SUPPL | 2012-04-13 |
| 35233 | SUPPL | 2010-10-19 |
| 3205 | SUPPL | 2010-10-19 |
| 20882 | SUPPL | 2007-11-19 |
| 35232 | SUPPL | 2007-03-31 |
| 25636 | SUPPL | 2007-03-31 |
| 25635 | SUPPL | 2005-08-11 |
| 13289 | SUPPL | 2005-08-11 |
| 13288 | SUPPL | 2004-07-21 |
| 3204 | SUPPL | 2004-07-21 |
| 35230 | SUPPL | 2004-05-26 |
| 35229 | SUPPL | 2004-05-26 |
| 25634 | SUPPL | 2004-05-26 |
| 25633 | SUPPL | 2004-05-26 |
| 13287 | SUPPL | 2004-05-26 |
| 3202 | SUPPL | 2004-05-26 |
| 35231 | SUPPL | 2004-04-05 |
| 3203 | SUPPL | 2004-03-03 |
| 35228 | SUPPL | 2003-04-22 |
| 51986 | SUPPL | 1900-01-01 |
| 51985 | SUPPL | 1900-01-01 |
| 51984 | SUPPL | 1900-01-01 |
| 51983 | SUPPL | 1900-01-01 |
| 51982 | SUPPL | 1900-01-01 |
| 51981 | SUPPL | 1900-01-01 |
| 51980 | SUPPL | 1900-01-01 |
| 51979 | SUPPL | 1900-01-01 |