Skip to contentApplication 020969
- Type
- NDA
- Sponsor
- MALLINCKRODT HOSP
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | UVADEX | METHOXSALEN | INJECTABLE;INJECTION | 0.02MG/ML | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 64067-216 | UVADEX | Methoxsalen | Therakos, Inc. | NDA | Current |
| 64067-216 | UVADEX | Methoxsalen | Therakos, Inc. | NDA | Current |
| 64067-216 | UVADEX | Methoxsalen | Therakos, Inc. | NDA | Current |
| 64067-216 | UVADEX | Methoxsalen | Therakos, Inc. | NDA | Current |
| 64067-216 | UVADEX | Methoxsalen | Therakos, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 66882 | SUPPL | 2021-03-26 |
| 66822 | SUPPL | 2021-03-22 |
| 51033 | SUPPL | 2018-01-11 |
| 51000 | SUPPL | 2018-01-09 |
| 26310 | SUPPL | 2013-11-06 |
| 13827 | SUPPL | 2013-11-01 |
| 35731 | ORIG | 1999-02-25 |
| 21307 | ORIG | 1999-02-25 |
| 3864 | ORIG | 1999-02-25 |