FDA.reportPublic FDA data

Application 210283

Type
ANDA
Sponsor
HOSPIRA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLOFARABINECLOFARABINESOLUTION;INTRAVENOUS20MG/20ML (1MG/ML)NoNo

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

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
A210283-001CLOFARABINECLOFARABINE20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUS2018-12-27

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 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A210283-001CLOFARABINE20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUS2018-12-27f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210283-001CLOFARABINE20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUS2018-12-27e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210283-001CLOFARABINE20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUS2018-12-27cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210283-001CLOFARABINE20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUS2018-12-27a50c72e98297…

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CLOFARABINECLOFARABINENovadoz Pharmaceuticals LLC26b2de66-6518-49ab-820e-492454cbc8732026-08-24Warnings, Adverse reactionsName fallback
brand name: CLOFARABINE
generic name: CLOFARABINE
ClofarabineCLOFARABINEDr.Reddy's Laboratories Inc0da6764d-5fac-7e0f-ea3e-a5aee55a8b2d2024-02-27Warnings, Adverse reactionsName fallback
brand name: Clofarabine
generic name: CLOFARABINE
CLOFARABINECLOFARABINEFosun Pharma USA Inc.e956b1e0-2829-4872-8c09-99462d60e9222023-02-15Warnings, Adverse reactionsName fallback
brand name: CLOFARABINE
generic name: CLOFARABINE
ClofarabineCLOFARABINEMeitheal Pharmaceuticals Inc.54436453-882e-406b-87a3-049d150101c62022-12-12Warnings, Adverse reactionsName fallback
brand name: Clofarabine
generic name: CLOFARABINE
ClofarabineCLOFARABINEGland Pharma Limitedb7d3a96e-0280-4f14-b921-795996f759502022-11-21Warnings, Adverse reactionsName fallback
brand name: Clofarabine
generic name: CLOFARABINE
CLOFARABINECLOFARABINEZydus Lifesciences Limited4d8d8e81-01ba-4493-b458-7f6375c5bbae2022-10-18Name fallback
brand name: CLOFARABINE
generic name: CLOFARABINE
CLOFARABINECLOFARABINEEugia US LLC18adf4af-63ed-41e6-ab59-87085ce3e5fb2022-10-10Warnings, Adverse reactionsName fallback
brand name: CLOFARABINE
generic name: CLOFARABINE
ClofarabineCLOFARABINEAmneal Pharmaceuticals LLC0a273a2d-a1ff-412a-925e-696648730dae2022-08-23Warnings, Adverse reactionsName fallback
brand name: Clofarabine
generic name: CLOFARABINE
CLOFARABINECLOFARABINEFresenius Kabi USA, LLCfe6ff0f9-7610-4a69-9b75-da7ec4bb77442020-07-14Warnings, Adverse reactionsName fallback
brand name: CLOFARABINE
generic name: CLOFARABINE

Reported adverse events (FAERS/openFDA)#

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