Application 022129
- Type
- NDA
- Sponsor
- SHIONOGI INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ULESFIA | BENZYL ALCOHOL | LOTION;TOPICAL | 5% | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 23594-780 | Ulesfia | benzyl alcohol | Cerecor, Inc. | NDA | Current |
| 23594-780 | Ulesfia | benzyl alcohol | Zylera Pharmaceuticals, L | NDA | Current |
| 69202-780 | Ulesfia | benzyl alcohol | Lachlan Pharmaceuticals | NDA | Current |
| 69202-780 | Ulesfia | benzyl alcohol | Lachlan Pharmaceuticals | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 62692 | SUPPL | 2020-04-27 |
| 62683 | SUPPL | 2020-04-27 |
| 38293 | SUPPL | 2012-07-30 |
| 29303 | SUPPL | 2012-07-17 |
| 17000 | SUPPL | 2010-06-24 |
| 6947 | SUPPL | 2010-06-24 |
| 24248 | ORIG | 2009-06-01 |
| 21944 | ORIG | 2009-06-01 |
| 38292 | ORIG | 2009-04-16 |
| 29302 | ORIG | 2009-04-16 |
| 53189 | ORIG | 1900-01-01 |
| 53188 | ORIG | 1900-01-01 |
| 53187 | ORIG | 1900-01-01 |