Home Applications 022041 Application 022041
Type NDA
Sponsor SERB SA Application Products# Product, Drug, Ingredient table 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
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table 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.
Product history page 1 of 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 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…2022-03-09 01:35 UTC 2022-03 N022041-001 CYANOKIT 5GM/VIAL (5GM/KIT) INJECTABLE / INJECTION RLD, RS 2011-04-08 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022041-002 CYANOKIT 2.5GM/VIAL (5GM/KIT) INJECTABLE / INJECTION 2006-12-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022041-001 CYANOKIT 5GM/VIAL (5GM/KIT) INJECTABLE / INJECTION RLD, RS 2011-04-08 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022041-002 CYANOKIT 2.5GM/VIAL (5GM/KIT) INJECTABLE / INJECTION 2006-12-15 782e0a99824c…
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.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table 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