FDA.reportPublic FDA data

Application 208435

Type
ANDA
Sponsor
AREVA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FUROSEMIDEFUROSEMIDEINJECTABLE;INJECTION10MG/MLNoNo

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
A208435-001FUROSEMIDEFUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP2020-12-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208435-001AP

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 22:54:322026-06A208435-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP2020-12-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A208435-001AP1a50c72e98297…

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 8 · 150 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FUROSCIXFUROSEMIDE INJECTION 80 MG/ 10 MLscPharmaceuticals Inc., a wholly owned subsidiary of MannKind Corporationeac958dd-8d43-e44e-e053-2995a90a4d5e2026-07-27Warnings, Adverse reactionsName fallback
generic name: FUROSEMIDE
FurosemideFUROSEMIDEREMEDYREPACK INC.7cdcd001-ab4b-4210-a455-2e17a7bc49722026-07-24Warnings, Adverse reactionsName fallback
brand name: Furosemide
generic name: FUROSEMIDE
FurosemideFUROSEMIDEREMEDYREPACK INC.3d312ab0-589c-427b-84da-18887244bfc92026-07-15Warnings, Adverse reactionsName fallback
brand name: Furosemide
generic name: FUROSEMIDE
FurosemideFUROSEMIDESt. Mary's Medical Park Pharmacyfebeaf8c-0f4b-cc40-e053-6394a90a873e2026-06-30Warnings, Adverse reactionsName fallback
brand name: Furosemide
generic name: FUROSEMIDE
FurosemideFUROSEMIDEREMEDYREPACK INC.916de29e-228c-4dfc-bcee-ad9a641316bd2026-06-24Warnings, Adverse reactionsName fallback
brand name: Furosemide
generic name: FUROSEMIDE
FurosemideFUROSEMIDEREMEDYREPACK INC.e8c27f1c-dc81-44b1-8663-a7d663bad89f2026-06-23Warnings, Adverse reactionsName fallback
brand name: Furosemide
generic name: FUROSEMIDE
FurosemideFUROSEMIDEREMEDYREPACK INC.571a52ed-5258-46d5-a0d2-9a984cf738952026-06-23Warnings, Adverse reactionsName fallback
brand name: Furosemide
generic name: FUROSEMIDE
FurosemideFUROSEMIDEAtlantic Biologicals Corp.54ed0dd9-2fa8-269a-e063-6294a90a607c2026-06-23Warnings, Adverse reactionsName fallback
brand name: Furosemide
generic name: FUROSEMIDE
FUROSEMIDEFUROSEMIDEHF Acquisition Co LLC, DBA HealthFirst75d5611a-f9e0-1841-e053-2991aa0af4152026-06-23Warnings, Adverse reactionsName fallback
brand name: FUROSEMIDE
generic name: FUROSEMIDE
FurosemideFUROSEMIDEUnit Dose Solutions, Inc.54dd664a-c7ec-27f3-e063-6294a90aff9f2026-06-22Warnings, Adverse reactionsName fallback
brand name: Furosemide
generic name: FUROSEMIDE
FurosemideFUROSEMIDECardinal Health 107, LLC2a5bcf50-6d63-463a-915e-a72ea2e5f1312026-06-18Warnings, Adverse reactionsName fallback
brand name: Furosemide
generic name: FUROSEMIDE
FurosemideFUROSEMIDEGranulation Technology, Inc.462e8917-cbe0-f4f9-e063-6394a90ab4ff2026-06-17Warnings, Adverse reactionsName fallback
brand name: Furosemide
generic name: FUROSEMIDE
FurosemideFUROSEMIDEAtlantic Biologicals Corps9c342198-7162-4cc5-bda1-bc4054a4292b2026-06-16Warnings, Adverse reactionsName fallback
brand name: Furosemide
generic name: FUROSEMIDE
FurosemideFUROSEMIDECoupler LLC53e58232-f7f9-c09b-e063-6394a90a5bc42026-06-10Warnings, Adverse reactionsName fallback
brand name: Furosemide
generic name: FUROSEMIDE
FurosemideFUROSEMIDECardinal Health 107, LLC42478c55-9056-487a-89a9-d36904beea122026-06-02Warnings, Adverse reactionsName fallback
brand name: Furosemide
generic name: FUROSEMIDE
FurosemideFUROSEMIDEMajor Pharmaceuticals6be1addd-a811-47fc-8650-6870d661c2342026-05-26Warnings, Adverse reactionsName fallback
brand name: Furosemide
generic name: FUROSEMIDE
FurosemideFUROSEMIDECardinal Health 107, LLC71b48f4d-9936-448c-9e3a-33f1182e10392026-05-15Warnings, Adverse reactionsName fallback
brand name: Furosemide
generic name: FUROSEMIDE
FurosemideFUROSEMIDEHospira, Inc.39fd32f2-6bb7-4a65-d298-e48d26bc80c72026-05-13Warnings, Adverse reactionsName fallback
brand name: Furosemide
generic name: FUROSEMIDE
FUROSEMIDEFUROSEMIDEHospira, Inc.aaced7a8-c3d7-4d66-8c07-aa407b8b3f352026-05-13Warnings, Adverse reactionsName fallback
brand name: FUROSEMIDE
generic name: FUROSEMIDE
FurosemideFUROSEMIDECardinal Health 107, LLC8e0bac29-5a8b-4d4e-93b3-2e21eb3b06502026-05-06Warnings, Adverse reactionsName fallback
brand name: Furosemide
generic name: FUROSEMIDE