Application 070014

Type
ANDA
Sponsor
ASTRAZENECA

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A070014-001FUROSEMIDEFUROSEMIDE10MG/MLINJECTABLE / INJECTION1985-09-09

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A070014-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1985-09-0984e616aacf4f…
2026-08-18 06:07:402026-07A070014-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1985-09-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A070014-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1985-09-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070014-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1985-09-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A070014-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1985-09-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070014-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1985-09-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070014-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1985-09-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070014-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1985-09-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070014-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1985-09-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070014-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1985-09-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070014-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1985-09-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070014-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1985-09-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070014-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1985-09-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070014-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1985-09-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070014-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1985-09-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070014-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1985-09-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070014-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1985-09-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070014-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1985-09-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070014-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1985-09-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070014-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1985-09-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070014-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1985-09-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070014-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1985-09-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070014-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1985-09-0987673890dc5c…
2021-03-12 10:30 UTC2021-03A070014-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1985-09-095aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070014-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1985-09-098869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070014-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1985-09-09c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070014-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1985-09-093f01610625f2…
2019-09-15 20:21 UTC2019-09A070014-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1985-09-09b00525d2431f…
2019-07-19 19:46 UTC2019-07A070014-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1985-09-09ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A070014-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1985-09-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A070014-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1985-09-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12A070014-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1985-09-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A070014-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1985-09-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A070014-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1985-09-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A070014-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1985-09-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A070014-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1985-09-093f0d92c62455…
2023-05-13 08:27 UTC2023-05A070014-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1985-09-09053a50430f4f…
2023-01-26 05:58 UTC2023-01A070014-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1985-09-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A070014-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1985-09-093a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A070014-001FUROSEMIDE10MG/MLINJECTABLE / INJECTION1985-09-09f41ea6bd6efb…

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 2 of 8 · 148 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
FurosemideFUROSEMIDEPreferred Pharmaceuticals, Inc.a23fc1e0-2d16-43a8-a34e-f6505dcd63162026-04-29Warnings, Adverse reactionsName fallback
brand name: Furosemide
generic name: FUROSEMIDE
FurosemideFUROSEMIDEPreferred Pharmaceuticals Inc.cad102d7-0197-4cff-bb80-9f0b5bcb599b2026-04-29Warnings, Adverse reactionsName fallback
brand name: Furosemide
generic name: FUROSEMIDE
FurosemideFUROSEMIDEREMEDYREPACK INC.7181e528-c862-4dd7-8446-9011e4c7312a2026-04-23Warnings, Adverse reactionsName fallback
brand name: Furosemide
generic name: FUROSEMIDE
FurosemideFUROSEMIDERedpharm Drug37457273-38a1-f938-e063-6294a90a50ab2026-04-15Warnings, Adverse reactionsName fallback
brand name: Furosemide
generic name: FUROSEMIDE
FurosemideFUROSEMIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.1b9117d5-0dd9-4577-a1fd-bb0aaf7e68ec2026-03-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Furosemide
generic name: FUROSEMIDE
FurosemideFUROSEMIDECoupler LLC4cc2c2d1-2fa4-f6b6-e063-6294a90a290e2026-03-11Warnings, Adverse reactionsName fallback
brand name: Furosemide
generic name: FUROSEMIDE
FurosemideFUROSEMIDEDirect_Rxe9be5c3b-4b18-7ad2-e053-2995a90a4a8b2026-03-09Warnings, Adverse reactionsName fallback
brand name: Furosemide
generic name: FUROSEMIDE
FurosemideFUROSEMIDEMarlex Pharmaceuticals, Inc.4bd1b15e-354e-051f-e063-6294a90a3f3b2026-03-01Warnings, Adverse reactionsName fallback
brand name: Furosemide
generic name: FUROSEMIDE
FurosemideFUROSEMIDENuCare Pharmaceuticals,Inc.bd45c963-a413-e9a1-e053-2a95a90a14382026-02-19Warnings, Adverse reactionsName fallback
brand name: Furosemide
generic name: FUROSEMIDE
FurosemideFUROSEMIDEPreferred Pharmaceuticals Inc.adda78ee-0cf5-4613-a748-5d6571afe3542026-01-19Warnings, Adverse reactionsName fallback
brand name: Furosemide
generic name: FUROSEMIDE
FUROSEMIDEFUROSEMIDECardinal Health 107, LLC2590ebb6-ce2a-4e23-9244-e54e3010d4882026-01-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: FUROSEMIDE
generic name: FUROSEMIDE
FurosemideFUROSEMIDEAvKAREd4c532be-1f3f-60d3-e053-2995a90a98be2026-01-14Warnings, Adverse reactionsName fallback
brand name: Furosemide
generic name: FUROSEMIDE
FurosemideFUROSEMIDEMeitheal Pharmaceuticals Inc.a2e3c748-28ce-4c50-a182-7219129198402026-01-14Warnings, Adverse reactionsName fallback
brand name: Furosemide
generic name: FUROSEMIDE
FurosemideFUROSEMIDEA-S Medication Solutions8f56d6f6-a5ea-4171-9e24-d2fdb11a65f82026-01-13Warnings, Adverse reactionsName fallback
brand name: Furosemide
generic name: FUROSEMIDE
FurosemideFUROSEMIDEMicro Labs Limited2f547f7c-0322-465c-9764-43f955d98ab22026-01-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Furosemide
generic name: FUROSEMIDE
FurosemideFUROSEMIDEPhlow Corporation08a44bdd-028d-41af-9d4e-70971b0bcc4e2026-01-09Warnings, Adverse reactionsName fallback
brand name: Furosemide
generic name: FUROSEMIDE
FurosemideFUROSEMIDENorthwind Health Company, LLC13ba97a7-598a-76a4-e063-6294a90a45c52026-01-02Warnings, Adverse reactionsName fallback
brand name: Furosemide
generic name: FUROSEMIDE
FUROSEMIDEFUROSEMIDENorthwind Health Company, LLC1d99e151-75ba-6a75-e063-6294a90a43602026-01-01Warnings, Adverse reactionsName fallback
brand name: FUROSEMIDE
generic name: FUROSEMIDE

Reported adverse events (FAERS/openFDA)#

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