Application 204153
- Type
- NDA
- Sponsor
- MEDICIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LUZU | LULICONAZOLE | CREAM;TOPICAL | 1% | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68682-850 | LULICONAZOLE | LULICONAZOLE | Oceanside Pharmaceuticals | NDA | Current |
| 68682-850 | LULICONAZOLE | LULICONAZOLE | Oceanside Pharmaceuticals | NDA | Current |
| 68682-850 | LULICONAZOLE | LULICONAZOLE | Oceanside Pharmaceuticals | NDA | Current |
| 68682-850 | LULICONAZOLE | LULICONAZOLE | Oceanside Pharmaceuticals | NDA | Current |
| 99207-850 | Luzu | LULICONAZOLE | Bausch Health US, LLC | NDA | Current |
| 99207-850 | Luzu | LULICONAZOLE | Bausch Health US, LLC | NDA | Current |
| 99207-850 | Luzu | LULICONAZOLE | Bausch Health US, LLC | NDA | Current |
| 99207-850 | Luzu | LULICONAZOLE | Valeant Pharmaceuticals North America LLC | NDA | Current |
| 99207-850 | Luzu | LULICONAZOLE | Bausch Health US, LLC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 52729 | SUPPL | 2018-02-26 |
| 52728 | SUPPL | 2018-02-26 |
| 52691 | SUPPL | 2018-02-23 |
| 52690 | SUPPL | 2018-02-23 |
| 47148 | SUPPL | 2017-02-09 |
| 47139 | SUPPL | 2017-02-09 |
| 43457 | ORIG | 2013-12-12 |
| 24460 | ORIG | 2013-12-12 |
| 32521 | ORIG | 2013-11-15 |
| 19531 | ORIG | 2013-11-15 |
| 63130 | SUPPL | 1900-01-01 |
| 63129 | SUPPL | 1900-01-01 |
| 63128 | SUPPL | 1900-01-01 |
| 63127 | SUPPL | 1900-01-01 |
| 63126 | SUPPL | 1900-01-01 |
| 63125 | SUPPL | 1900-01-01 |
| 63124 | SUPPL | 1900-01-01 |