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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022041-001 | CYANOKIT | HYDROXOCOBALAMIN | 5GM/VIAL (5GM/KIT) | INJECTABLE / INJECTION | RLD, RS | 2011-04-08 | |
| N022041-002 | CYANOKIT | HYDROXOCOBALAMIN | 2.5GM/VIAL (5GM/KIT) | INJECTABLE / INJECTION | 2006-12-15 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N022041-001 | CYANOKIT | 5GM/VIAL (5GM/KIT) | INJECTABLE / INJECTION | RLD, RS | 2011-04-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022041-002 | CYANOKIT | 2.5GM/VIAL (5GM/KIT) | INJECTABLE / INJECTION | 2006-12-15 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022041-001 | CYANOKIT | 5GM/VIAL (5GM/KIT) | INJECTABLE / INJECTION | RLD, RS | 2011-04-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022041-002 | CYANOKIT | 2.5GM/VIAL (5GM/KIT) | INJECTABLE / INJECTION | 2006-12-15 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022041-001 | CYANOKIT | 5GM/VIAL (5GM/KIT) | INJECTABLE / INJECTION | RLD, RS | 2011-04-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022041-002 | CYANOKIT | 2.5GM/VIAL (5GM/KIT) | INJECTABLE / INJECTION | 2006-12-15 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022041-001 | CYANOKIT | 5GM/VIAL (5GM/KIT) | INJECTABLE / INJECTION | RLD, RS | 2011-04-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022041-002 | CYANOKIT | 2.5GM/VIAL (5GM/KIT) | INJECTABLE / INJECTION | 2006-12-15 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N022041-001 | CYANOKIT | 5GM/VIAL (5GM/KIT) | INJECTABLE / INJECTION | RLD, RS | 2011-04-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022041-002 | CYANOKIT | 2.5GM/VIAL (5GM/KIT) | INJECTABLE / INJECTION | 2006-12-15 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022041-001 | CYANOKIT | 5GM/VIAL (5GM/KIT) | INJECTABLE / INJECTION | RLD, RS | 2011-04-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022041-002 | CYANOKIT | 2.5GM/VIAL (5GM/KIT) | INJECTABLE / INJECTION | 2006-12-15 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022041-001 | CYANOKIT | 5GM/VIAL (5GM/KIT) | INJECTABLE / INJECTION | RLD, RS | 2011-04-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022041-002 | CYANOKIT | 2.5GM/VIAL (5GM/KIT) | INJECTABLE / INJECTION | 2006-12-15 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022041-001 | CYANOKIT | 5GM/VIAL (5GM/KIT) | INJECTABLE / INJECTION | RLD, RS | 2011-04-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022041-002 | CYANOKIT | 2.5GM/VIAL (5GM/KIT) | INJECTABLE / INJECTION | 2006-12-15 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022041-001 | CYANOKIT | 5GM/VIAL (5GM/KIT) | INJECTABLE / INJECTION | RLD, RS | 2011-04-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022041-002 | CYANOKIT | 2.5GM/VIAL (5GM/KIT) | INJECTABLE / INJECTION | 2006-12-15 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022041-001 | CYANOKIT | 5GM/VIAL (5GM/KIT) | INJECTABLE / INJECTION | RLD, RS | 2011-04-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022041-002 | CYANOKIT | 2.5GM/VIAL (5GM/KIT) | INJECTABLE / INJECTION | 2006-12-15 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022041-001 | CYANOKIT | 5GM/VIAL (5GM/KIT) | INJECTABLE / INJECTION | RLD, RS | 2011-04-08 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022041-002 | CYANOKIT | 2.5GM/VIAL (5GM/KIT) | INJECTABLE / INJECTION | 2006-12-15 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N022041-001 | CYANOKIT | 5GM/VIAL (5GM/KIT) | INJECTABLE / INJECTION | RLD, RS | 2011-04-08 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022041-002 | CYANOKIT | 2.5GM/VIAL (5GM/KIT) | INJECTABLE / INJECTION | 2006-12-15 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022041-001 | CYANOKIT | 5GM/VIAL (5GM/KIT) | INJECTABLE / INJECTION | RLD, RS | 2011-04-08 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022041-002 | CYANOKIT | 2.5GM/VIAL (5GM/KIT) | INJECTABLE / INJECTION | 2006-12-15 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022041-001 | CYANOKIT | 5GM/VIAL (5GM/KIT) | INJECTABLE / INJECTION | RLD, RS | 2011-04-08 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022041-002 | CYANOKIT | 2.5GM/VIAL (5GM/KIT) | INJECTABLE / INJECTION | 2006-12-15 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022041-001 | CYANOKIT | 5GM/VIAL (5GM/KIT) | INJECTABLE / INJECTION | RLD, RS | 2011-04-08 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022041-002 | CYANOKIT | 2.5GM/VIAL (5GM/KIT) | INJECTABLE / INJECTION | 2006-12-15 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N022041-001 | CYANOKIT | 5GM/VIAL (5GM/KIT) | INJECTABLE / INJECTION | RLD, RS | 2011-04-08 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N022041-002 | CYANOKIT | 2.5GM/VIAL (5GM/KIT) | INJECTABLE / INJECTION | 2006-12-15 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022041-001 | CYANOKIT | 5GM/VIAL (5GM/KIT) | INJECTABLE / INJECTION | RLD, RS | 2011-04-08 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022041-002 | CYANOKIT | 2.5GM/VIAL (5GM/KIT) | INJECTABLE / INJECTION | 2006-12-15 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N022041-001 | CYANOKIT | 5GM/VIAL (5GM/KIT) | INJECTABLE / INJECTION | RLD, RS | 2011-04-08 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022041-002 | CYANOKIT | 2.5GM/VIAL (5GM/KIT) | INJECTABLE / INJECTION | 2006-12-15 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N022041-001 | CYANOKIT | 5GM/VIAL (5GM/KIT) | INJECTABLE / INJECTION | RLD, RS | 2011-04-08 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N022041-002 | CYANOKIT | 2.5GM/VIAL (5GM/KIT) | INJECTABLE / INJECTION | 2006-12-15 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N022041-001 | CYANOKIT | 5GM/VIAL (5GM/KIT) | INJECTABLE / INJECTION | RLD, RS | 2011-04-08 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N022041-002 | CYANOKIT | 2.5GM/VIAL (5GM/KIT) | INJECTABLE / INJECTION | 2006-12-15 | 74a2ff9319b5… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Cyanokit | HYDROXOCOBALAMIN | BTG INTERNATIONAL INC. | d56fcc8d-bd64-46ab-b0c0-2124bd745a6b | 2023-04-27 | Warnings, Adverse reactions | 022041 NDA022041 50633-310 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 |