Application 022041
- Type
- NDA
- Sponsor
- SERB SA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CYANOKIT | HYDROXOCOBALAMIN | INJECTABLE;INJECTION | 5GM/VIAL (5GM/KIT) | Yes | Yes |
| 002 | CYANOKIT | HYDROXOCOBALAMIN | INJECTABLE;INJECTION | 2.5GM/VIAL (5GM/KIT) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 11704-370 | Cyanokit | Hydroxocobalamin | Meridian Medical Technologies, Inc. | NDA | Current |
| 11704-370 | Cyanokit | Hydroxocobalamin | Meridian Medical Technologies, Inc. | NDA | Current |
| 11704-370 | Cyanokit | Hydroxocobalamin | Meridian Medical Technologies, Inc. | NDA | Current |
| 11704-370 | Cyanokit | Hydroxocobalamin | Meridian Medical Technologies, Inc. | NDA | Current |
| 11704-370 | Cyanokit | Hydroxocobalamin | Meridian Medical Technologies, Inc. | NDA | Current |
| 50633-310 | Cyanokit | Hydroxocobalamin | BTG INTERNATIONAL INC. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 57111 | SUPPL | 2019-01-03 |
| 57110 | SUPPL | 2019-01-03 |
| 57096 | SUPPL | 2019-01-02 |
| 57095 | SUPPL | 2019-01-02 |
| 38124 | SUPPL | 2011-04-11 |
| 16816 | SUPPL | 2011-04-11 |
| 38123 | SUPPL | 2010-10-19 |
| 29125 | SUPPL | 2010-10-19 |
| 16815 | SUPPL | 2010-03-03 |
| 29127 | SUPPL | 2010-02-26 |
| 29126 | SUPPL | 2009-06-16 |
| 16814 | SUPPL | 2009-06-10 |
| 21915 | ORIG | 2008-12-12 |
| 6743 | ORIG | 2007-03-26 |
| 16813 | ORIG | 2006-12-19 |