FDA.reportPublic FDA data

Application 022041

Type
NDA
Sponsor
SERB SA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CYANOKITHYDROXOCOBALAMININJECTABLE;INJECTION5GM/VIAL (5GM/KIT)YesYes
002CYANOKITHYDROXOCOBALAMININJECTABLE;INJECTION2.5GM/VIAL (5GM/KIT)NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022041-001CYANOKITHYDROXOCOBALAMIN5GM/VIAL (5GM/KIT)INJECTABLE / INJECTIONRLD, RS2011-04-08
N022041-002CYANOKITHYDROXOCOBALAMIN2.5GM/VIAL (5GM/KIT)INJECTABLE / INJECTION2006-12-15

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2019-12-13 00:20 UTC2019-12N022041-001CYANOKIT5GM/VIAL (5GM/KIT)INJECTABLE / INJECTIONRLD, RS2011-04-0874a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022041-002CYANOKIT2.5GM/VIAL (5GM/KIT)INJECTABLE / INJECTION2006-12-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022041-001CYANOKIT5GM/VIAL (5GM/KIT)INJECTABLE / INJECTIONRLD, RS2011-04-08bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N022041-002CYANOKIT2.5GM/VIAL (5GM/KIT)INJECTABLE / INJECTION2006-12-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022041-001CYANOKIT5GM/VIAL (5GM/KIT)INJECTABLE / INJECTIONRLD, RS2011-04-08782e0a99824c…
2021-12-28 21:50 UTC2021-12N022041-002CYANOKIT2.5GM/VIAL (5GM/KIT)INJECTABLE / INJECTION2006-12-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022041-001CYANOKIT5GM/VIAL (5GM/KIT)INJECTABLE / INJECTIONRLD, RS2011-04-0887673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022041-002CYANOKIT2.5GM/VIAL (5GM/KIT)INJECTABLE / INJECTION2006-12-1587673890dc5c…
2021-03-12 10:30 UTC2021-03N022041-001CYANOKIT5GM/VIAL (5GM/KIT)INJECTABLE / INJECTIONRLD, RS2011-04-085aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N022041-002CYANOKIT2.5GM/VIAL (5GM/KIT)INJECTABLE / INJECTION2006-12-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022041-001CYANOKIT5GM/VIAL (5GM/KIT)INJECTABLE / INJECTIONRLD, RS2011-04-088869cabd3fbd…
2020-12-22 03:56 UTC2020-12N022041-002CYANOKIT2.5GM/VIAL (5GM/KIT)INJECTABLE / INJECTION2006-12-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022041-001CYANOKIT5GM/VIAL (5GM/KIT)INJECTABLE / INJECTIONRLD, RS2011-04-08c0c555d07b60…
2020-11-12 02:37 UTC2020-11N022041-002CYANOKIT2.5GM/VIAL (5GM/KIT)INJECTABLE / INJECTION2006-12-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022041-001CYANOKIT5GM/VIAL (5GM/KIT)INJECTABLE / INJECTIONRLD, RS2011-04-083f01610625f2…
2019-12-14 00:12 UTC2019-12N022041-002CYANOKIT2.5GM/VIAL (5GM/KIT)INJECTABLE / INJECTION2006-12-153f01610625f2…
2019-09-15 20:21 UTC2019-09N022041-001CYANOKIT5GM/VIAL (5GM/KIT)INJECTABLE / INJECTIONRLD, RS2011-04-08b00525d2431f…
2019-09-15 20:21 UTC2019-09N022041-002CYANOKIT2.5GM/VIAL (5GM/KIT)INJECTABLE / INJECTION2006-12-15b00525d2431f…
2019-07-19 19:46 UTC2019-07N022041-001CYANOKIT5GM/VIAL (5GM/KIT)INJECTABLE / INJECTIONRLD, RS2011-04-08ea99ee380514…
2019-07-19 19:46 UTC2019-07N022041-002CYANOKIT2.5GM/VIAL (5GM/KIT)INJECTABLE / INJECTION2006-12-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022041-001CYANOKIT5GM/VIAL (5GM/KIT)INJECTABLE / INJECTIONRLD, RS2011-04-086a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022041-002CYANOKIT2.5GM/VIAL (5GM/KIT)INJECTABLE / INJECTION2006-12-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022041-001CYANOKIT5GM/VIAL (5GM/KIT)INJECTABLE / INJECTIONRLD, RS2011-04-081c564ffb4f44…
2024-02-18 07:12 UTC2024-02N022041-002CYANOKIT2.5GM/VIAL (5GM/KIT)INJECTABLE / INJECTION2006-12-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022041-001CYANOKIT5GM/VIAL (5GM/KIT)INJECTABLE / INJECTIONRLD, RS2011-04-08ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N022041-002CYANOKIT2.5GM/VIAL (5GM/KIT)INJECTABLE / INJECTION2006-12-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022041-001CYANOKIT5GM/VIAL (5GM/KIT)INJECTABLE / INJECTIONRLD, RS2011-04-08a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022041-002CYANOKIT2.5GM/VIAL (5GM/KIT)INJECTABLE / INJECTION2006-12-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022041-001CYANOKIT5GM/VIAL (5GM/KIT)INJECTABLE / INJECTIONRLD, RS2011-04-089b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022041-002CYANOKIT2.5GM/VIAL (5GM/KIT)INJECTABLE / INJECTION2006-12-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022041-001CYANOKIT5GM/VIAL (5GM/KIT)INJECTABLE / INJECTIONRLD, RS2011-04-08a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022041-002CYANOKIT2.5GM/VIAL (5GM/KIT)INJECTABLE / INJECTION2006-12-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022041-001CYANOKIT5GM/VIAL (5GM/KIT)INJECTABLE / INJECTIONRLD, RS2011-04-083f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022041-002CYANOKIT2.5GM/VIAL (5GM/KIT)INJECTABLE / INJECTION2006-12-153f0d92c62455…
2023-05-13 08:27 UTC2023-05N022041-001CYANOKIT5GM/VIAL (5GM/KIT)INJECTABLE / INJECTIONRLD, RS2011-04-08053a50430f4f…
2023-05-13 08:27 UTC2023-05N022041-002CYANOKIT2.5GM/VIAL (5GM/KIT)INJECTABLE / INJECTION2006-12-15053a50430f4f…
2023-01-26 05:58 UTC2023-01N022041-001CYANOKIT5GM/VIAL (5GM/KIT)INJECTABLE / INJECTIONRLD, RS2011-04-083bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N022041-002CYANOKIT2.5GM/VIAL (5GM/KIT)INJECTABLE / INJECTION2006-12-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022041-001CYANOKIT5GM/VIAL (5GM/KIT)INJECTABLE / INJECTIONRLD, RS2011-04-083a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022041-002CYANOKIT2.5GM/VIAL (5GM/KIT)INJECTABLE / INJECTION2006-12-153a93d1ddd44b…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CyanokitHYDROXOCOBALAMINBTG INTERNATIONAL INC.d56fcc8d-bd64-46ab-b0c0-2124bd745a6b2023-04-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 022041
application number: NDA022041
ndc (product): 50633-310

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
11704-370CyanokitHydroxocobalaminMeridian Medical Technologies, Inc.NDACurrent
11704-370CyanokitHydroxocobalaminMeridian Medical Technologies, Inc.NDACurrent
11704-370CyanokitHydroxocobalaminMeridian Medical Technologies, Inc.NDACurrent
11704-370CyanokitHydroxocobalaminMeridian Medical Technologies, Inc.NDACurrent
11704-370CyanokitHydroxocobalaminMeridian Medical Technologies, Inc.NDACurrent
50633-310CyanokitHydroxocobalaminBTG INTERNATIONAL INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57111SUPPL2019-01-03
57110SUPPL2019-01-03
57096SUPPL2019-01-02
57095SUPPL2019-01-02
38124SUPPL2011-04-11
16816SUPPL2011-04-11
38123SUPPL2010-10-19
29125SUPPL2010-10-19
16815SUPPL2010-03-03
29127SUPPL2010-02-26
29126SUPPL2009-06-16
16814SUPPL2009-06-10
21915ORIG2008-12-12
6743ORIG2007-03-26
16813ORIG2006-12-19