FDA.reportPublic FDA data

Application 020038

Type
NDA
Sponsor
GENZYME CORP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUDARAFLUDARABINE PHOSPHATEINJECTABLE;INJECTION50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

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
N020038-001FLUDARAFLUDARABINE PHOSPHATE50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1991-04-18

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 UTC2022-10N020038-001FLUDARA50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1991-04-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020038-001FLUDARA50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1991-04-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020038-001FLUDARA50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1991-04-18cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020038-001FLUDARA50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1991-04-18a50c72e98297…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FludarabineFLUDARABINE PHOSPHATEFresenius Kabi USA, LLCcf5255cc-91fd-4132-973b-764dba142eae2024-10-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUDARABINE PHOSPHATE
Fludarabine PhosphateFLUDARABINE PHOSPHATEAreva Pharmaceuticals8039c2e3-ffe5-3997-e053-2991aa0ad9d02023-02-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUDARABINE PHOSPHATE
Fludarabine PhosphateFLUDARABINE PHOSPHATELannett Company, Inc.0170c0f4-d502-4f8f-bdbf-6439f3ed33fb2023-01-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUDARABINE PHOSPHATE
Fludarabine phosphateFLUDARABINE PHOSPHATEActavis Pharma, Inc.3adca34b-4f65-4e21-8058-3c01fc7fc9bb2022-09-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUDARABINE PHOSPHATE
Fludarabine PhosphateFLUDARABINE PHOSPHATESagent Pharmaceuticals20e5acf0-90b7-45c8-be78-91eaf77c9ac02021-07-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUDARABINE PHOSPHATE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
1948SUPPL2010-08-02
34207SUPPL2010-07-31
1947SUPPL2009-02-13
34206SUPPL2009-02-12
21073SUPPL2008-01-09
12160SUPPL2007-12-27
34205SUPPL2003-08-14
1946SUPPL2003-08-14
34204SUPPL2003-04-21
63714SUPPL1900-01-01
63713SUPPL1900-01-01
51947ORIG1900-01-01
51946ORIG1900-01-01