FDA.reportPublic FDA data

Application 076349

Type
ANDA
Sponsor
CUSTOPHARM INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUDARABINE PHOSPHATEFLUDARABINE PHOSPHATEINJECTABLE;INJECTION50MG/VIALNoNo

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
A076349-001FLUDARABINE PHOSPHATEFLUDARABINE PHOSPHATE50MG/VIALINJECTABLE / INJECTIONAP2003-08-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076349-001AP

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A076349-001FLUDARABINE PHOSPHATE50MG/VIALINJECTABLE / INJECTIONAP2003-08-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A076349-001AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
brand name: Fludarabine Phosphate
generic name: FLUDARABINE PHOSPHATE
Fludarabine PhosphateFLUDARABINE PHOSPHATELannett Company, Inc.0170c0f4-d502-4f8f-bdbf-6439f3ed33fb2023-01-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fludarabine Phosphate
generic name: FLUDARABINE PHOSPHATE
Fludarabine phosphateFLUDARABINE PHOSPHATEActavis Pharma, Inc.3adca34b-4f65-4e21-8058-3c01fc7fc9bb2022-09-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fludarabine phosphate
generic name: FLUDARABINE PHOSPHATE
Fludarabine PhosphateFLUDARABINE PHOSPHATESagent Pharmaceuticals20e5acf0-90b7-45c8-be78-91eaf77c9ac02021-07-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fludarabine Phosphate
generic name: FLUDARABINE PHOSPHATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24201-237fludarabine phosphatefludarabine phosphateLeucadia PharmaceuticalsANDACurrent
24201-237fludarabine phosphatefludarabine phosphateHikma Pharmaceuticals USA Inc. (dba Leucadia Pharmaceuticals)ANDACurrent
25021-237fludarabine phosphatefludarabine phosphateSagent PharmaceuticalsANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22555ORIG2007-04-02