Application 018961

Type
NDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHROMIC CHLORIDE IN PLASTIC CONTAINERCHROMIC CHLORIDEINJECTABLE;INJECTIONEQ 0.004MG CHROMIUM/MLYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018961-001CHROMIC CHLORIDE IN PLASTIC CONTAINERCHROMIC CHLORIDEEQ 0.004MG CHROMIUM/MLINJECTABLE / INJECTIONAPRLD, RS1986-06-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N018961-001AP

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N018961-001CHROMIC CHLORIDE IN PLASTIC CONTAINEREQ 0.004MG CHROMIUM/MLINJECTABLE / INJECTIONAPRLD, RS1986-06-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018961-001CHROMIC CHLORIDE IN PLASTIC CONTAINEREQ 0.004MG CHROMIUM/MLINJECTABLE / INJECTIONAPRLD, RS1986-06-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N018961-001CHROMIC CHLORIDE IN PLASTIC CONTAINEREQ 0.004MG CHROMIUM/MLINJECTABLE / INJECTIONAPRLD, RS1986-06-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018961-001CHROMIC CHLORIDE IN PLASTIC CONTAINEREQ 0.004MG CHROMIUM/MLINJECTABLE / INJECTIONAPRLD, RS1986-06-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018961-001CHROMIC CHLORIDE IN PLASTIC CONTAINEREQ 0.004MG CHROMIUM/MLINJECTABLE / INJECTIONAPRLD, RS1986-06-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018961-001CHROMIC CHLORIDE IN PLASTIC CONTAINEREQ 0.004MG CHROMIUM/MLINJECTABLE / INJECTIONAPRLD, RS1986-06-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018961-001CHROMIC CHLORIDE IN PLASTIC CONTAINEREQ 0.004MG CHROMIUM/MLINJECTABLE / INJECTIONAPRLD, RS1986-06-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018961-001CHROMIC CHLORIDE IN PLASTIC CONTAINEREQ 0.004MG CHROMIUM/MLINJECTABLE / INJECTIONRLD, RS1986-06-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018961-001CHROMIC CHLORIDE IN PLASTIC CONTAINEREQ 0.004MG CHROMIUM/MLINJECTABLE / INJECTIONRLD, RS1986-06-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018961-001CHROMIC CHLORIDE IN PLASTIC CONTAINEREQ 0.004MG CHROMIUM/MLINJECTABLE / INJECTIONRLD, RS1986-06-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018961-001CHROMIC CHLORIDE IN PLASTIC CONTAINEREQ 0.004MG CHROMIUM/MLINJECTABLE / INJECTIONRLD, RS1986-06-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018961-001CHROMIC CHLORIDE IN PLASTIC CONTAINEREQ 0.004MG CHROMIUM/MLINJECTABLE / INJECTIONRLD, RS1986-06-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018961-001CHROMIC CHLORIDE IN PLASTIC CONTAINEREQ 0.004MG CHROMIUM/MLINJECTABLE / INJECTIONRLD, RS1986-06-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018961-001CHROMIC CHLORIDE IN PLASTIC CONTAINEREQ 0.004MG CHROMIUM/MLINJECTABLE / INJECTIONRLD, RS1986-06-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018961-001CHROMIC CHLORIDE IN PLASTIC CONTAINEREQ 0.004MG CHROMIUM/MLINJECTABLE / INJECTIONRLD, RS1986-06-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018961-001CHROMIC CHLORIDE IN PLASTIC CONTAINEREQ 0.004MG CHROMIUM/MLINJECTABLE / INJECTIONRLD, RS1986-06-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018961-001CHROMIC CHLORIDE IN PLASTIC CONTAINEREQ 0.004MG CHROMIUM/MLINJECTABLE / INJECTIONRLD, RS1986-06-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018961-001CHROMIC CHLORIDE IN PLASTIC CONTAINEREQ 0.004MG CHROMIUM/MLINJECTABLE / INJECTIONRLD, RS1986-06-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018961-001CHROMIC CHLORIDE IN PLASTIC CONTAINEREQ 0.004MG CHROMIUM/MLINJECTABLE / INJECTIONRLD, RS1986-06-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018961-001CHROMIC CHLORIDE IN PLASTIC CONTAINEREQ 0.004MG CHROMIUM/MLINJECTABLE / INJECTIONRLD, RS1986-06-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018961-001CHROMIC CHLORIDE IN PLASTIC CONTAINEREQ 0.004MG CHROMIUM/MLINJECTABLE / INJECTIONRLD, RS1986-06-2687673890dc5c…
2021-03-12 10:30 UTC2021-03N018961-001CHROMIC CHLORIDE IN PLASTIC CONTAINEREQ 0.004MG CHROMIUM/MLINJECTABLE / INJECTIONRLD, RS1986-06-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018961-001CHROMIC CHLORIDE IN PLASTIC CONTAINEREQ 0.004MG CHROMIUM/MLINJECTABLE / INJECTIONRLD, RS1986-06-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018961-001CHROMIC CHLORIDE IN PLASTIC CONTAINEREQ 0.004MG CHROMIUM/MLINJECTABLE / INJECTIONRLD, RS1986-06-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018961-001CHROMIC CHLORIDE IN PLASTIC CONTAINEREQ 0.004MG CHROMIUM/MLINJECTABLE / INJECTIONRLD, RS1986-06-263f01610625f2…
2019-09-15 20:21 UTC2019-09N018961-001CHROMIC CHLORIDE IN PLASTIC CONTAINEREQ 0.004MG CHROMIUM/MLINJECTABLE / INJECTIONRLD, RS1986-06-26b00525d2431f…
2019-07-19 19:46 UTC2019-07N018961-001CHROMIC CHLORIDE IN PLASTIC CONTAINEREQ 0.004MG CHROMIUM/MLINJECTABLE / INJECTIONRLD, RS1986-06-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018961-001CHROMIC CHLORIDE IN PLASTIC CONTAINEREQ 0.004MG CHROMIUM/MLINJECTABLE / INJECTIONRLD, RS1986-06-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018961-001CHROMIC CHLORIDE IN PLASTIC CONTAINEREQ 0.004MG CHROMIUM/MLINJECTABLE / INJECTIONRLD, RS1986-06-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018961-001CHROMIC CHLORIDE IN PLASTIC CONTAINEREQ 0.004MG CHROMIUM/MLINJECTABLE / INJECTIONRLD, RS1986-06-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018961-001CHROMIC CHLORIDE IN PLASTIC CONTAINEREQ 0.004MG CHROMIUM/MLINJECTABLE / INJECTIONRLD, RS1986-06-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018961-001CHROMIC CHLORIDE IN PLASTIC CONTAINEREQ 0.004MG CHROMIUM/MLINJECTABLE / INJECTIONRLD, RS1986-06-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018961-001CHROMIC CHLORIDE IN PLASTIC CONTAINEREQ 0.004MG CHROMIUM/MLINJECTABLE / INJECTIONRLD, RS1986-06-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018961-001CHROMIC CHLORIDE IN PLASTIC CONTAINEREQ 0.004MG CHROMIUM/MLINJECTABLE / INJECTIONRLD, RS1986-06-263f0d92c62455…
2023-05-13 08:27 UTC2023-05N018961-001CHROMIC CHLORIDE IN PLASTIC CONTAINEREQ 0.004MG CHROMIUM/MLINJECTABLE / INJECTIONRLD, RS1986-06-26053a50430f4f…
2023-01-26 05:58 UTC2023-01N018961-001CHROMIC CHLORIDE IN PLASTIC CONTAINEREQ 0.004MG CHROMIUM/MLINJECTABLE / INJECTIONRLD, RS1986-06-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018961-001CHROMIC CHLORIDE IN PLASTIC CONTAINEREQ 0.004MG CHROMIUM/MLINJECTABLE / INJECTIONRLD, RS1986-06-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018961-001CHROMIC CHLORIDE IN PLASTIC CONTAINEREQ 0.004MG CHROMIUM/MLINJECTABLE / INJECTIONRLD, RS1986-06-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018961-001CHROMIC CHLORIDE IN PLASTIC CONTAINEREQ 0.004MG CHROMIUM/MLINJECTABLE / INJECTIONRLD, RS1986-06-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N018961-001CHROMIC CHLORIDE IN PLASTIC CONTAINEREQ 0.004MG CHROMIUM/MLINJECTABLE / INJECTIONRLD, RS1986-06-26cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N018961-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018961-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018961-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018961-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018961-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018961-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018961-001AP12680178bc6a6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N018961-001AP1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CHROMIUMCHROMIC CHLORIDEHospira, Inc.b4d01ebb-a36e-44b7-028c-43c0ab2d13b42026-06-24Warnings, Adverse reactionsExact identifier
application applno (NDA): 018961
application number: NDA018961
ndc (product): 0409-4093
ChromiumCHROMIC CHLORIDEHospira, Inc.da207ca8-7836-4c66-92fe-36cc89baf7732026-06-24Warnings, Adverse reactionsExact identifier
application applno (NDA): 018961
application number: NDA018961
ndc (product): 0409-4093

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-4093CHROMIUMCHROMIC CHLORIDEHospira, Inc.NDACurrent
0409-4093CHROMIUMCHROMIC CHLORIDEHospira, Inc.NDACurrent
0409-4093CHROMIUMCHROMIC CHLORIDEHospira, Inc.NDACurrent
0409-4093ChromiumChromic ChlorideHospira, Inc.NDACurrent
0409-4093ChromiumChromic ChlorideHospira, Inc.NDACurrent
0409-4093ChromiumChromic ChlorideHospira, Inc.NDACurrent
0409-4093ChromiumChromic ChlorideHospira, Inc.NDACurrent
0409-4093CHROMIUMCHROMIC CHLORIDEHospira, Inc.NDACurrent
0409-4093CHROMIUMCHROMIC CHLORIDEHospira, Inc.NDACurrent
51662-1415CHROMIUM CHROMIC CHLORIDECHROMIUM CHROMIC CHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1415CHROMIUM CHROMIC CHLORIDECHROMIUM CHROMIC CHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
11384SUPPL2002-04-24
1154SUPPL2002-04-24