Application 212295
- Type
- NDA
- Sponsor
- COSMO TECHNOLOGIES LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BYFAVO | REMIMAZOLAM | INJECTABLE;INJECTION | 20MG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 71390-011 | BYFAVO | remimazolam besylate | Acacia Pharma Ltd | NDA | Current |
| 71390-011 | BYFAVO | remimazolam besylate | Acacia Pharma, Ltd. | NDA | Current |
| 71390-011 | BYFAVO | remimazolam besylate | Acacia Pharma Ltd | NDA | Current |
| 71390-011 | BYFAVO | remimazolam besylate | Acacia Pharma, Ltd. | NDA | Current |
| 71390-011 | BYFAVO | remimazolam besylate | Acacia Pharma, Ltd. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 73216 | SUPPL | 2023-01-17 |
| 68930 | ORIG | 2021-10-08 |
| 67024 | SUPPL | 2021-04-12 |
| 67011 | SUPPL | 2021-04-09 |
| 65450 | SUPPL | 2020-12-01 |
| 65440 | SUPPL | 2020-12-01 |
| 64155 | ORIG | 2020-07-31 |
| 63794 | ORIG | 2020-07-06 |
| 63788 | ORIG | 2020-07-02 |