Skip to contentApplication 211321
- Type
- NDA
- Sponsor
- UCB INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | NAYZILAM | MIDAZOLAM | SPRAY;NASAL | 5MG/SPRAY | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50474-500 | Nayzilam | midazolam | UCB, Inc. | NDA | Current |
| 50474-500 | Nayzilam | midazolam | UCB, Inc. | NDA | Current |
| 50474-500 | Nayzilam | midazolam | UCB, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 73204 | SUPPL | 2023-01-17 |
| 73203 | SUPPL | 2023-01-17 |
| 73186 | SUPPL | 2023-01-17 |
| 66155 | SUPPL | 2021-02-09 |
| 66154 | SUPPL | 2021-02-09 |
| 66142 | SUPPL | 2021-02-09 |
| 62096 | ORIG | 2020-03-10 |
| 59137 | ORIG | 2019-06-20 |
| 58764 | ORIG | 2019-05-17 |
| 58763 | ORIG | 2019-05-17 |