Application 020965
- Type
- NDA
- Sponsor
- DUSA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LEVULAN | AMINOLEVULINIC ACID HYDROCHLORIDE | SOLUTION;TOPICAL | 20% | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 67308-101 | LEVULAN KERASTICK | aminolevulinic acid hydrochloride | DUSA Pharmaceuticals, Inc. | NDA | Current |
| 67308-101 | LEVULAN KERASTICK | aminolevulinic acid hydrochloride | DUSA Pharmaceuticals, Inc. | NDA | Current |
| 67308-101 | LEVULAN KERASTICK | aminolevulinic acid hydrochloride | DUSA Pharmaceuticals, Inc. | NDA | Current |
| 67308-101 | LEVULAN KERASTICK | aminolevulinic acid hydrochloride | DUSA Pharmaceuticals, Inc. | NDA | Current |
| 67308-101 | LEVULAN KERASTICK | aminolevulinic acid hydrochloride | DUSA Pharmaceuticals, Inc. | NDA | Current |
| 67308-101 | LEVULAN KERASTICK | aminolevulinic acid hydrochloride | DUSA Pharmaceuticals, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 71045 | SUPPL | 2022-05-11 |
| 71031 | SUPPL | 2022-05-10 |
| 53784 | SUPPL | 2018-04-23 |
| 53749 | SUPPL | 2018-04-20 |
| 52913 | SUPPL | 2018-03-12 |
| 52872 | SUPPL | 2018-03-08 |
| 3856 | SUPPL | 2010-03-18 |
| 13821 | SUPPL | 2010-03-17 |
| 3855 | SUPPL | 2009-11-20 |
| 13820 | SUPPL | 2009-07-23 |
| 3854 | SUPPL | 2003-07-28 |
| 35724 | SUPPL | 2003-07-08 |
| 26304 | SUPPL | 2003-07-06 |
| 35723 | SUPPL | 2003-03-28 |
| 26303 | SUPPL | 2003-03-28 |
| 35722 | ORIG | 1999-12-07 |
| 21304 | ORIG | 1999-12-07 |
| 3853 | ORIG | 1999-12-07 |