Application 075241

Type
ANDA
Sponsor
HOSPIRA

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A075241-001FUROSEMIDEFUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1999-05-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075241-001AP

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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A075241-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1999-05-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075241-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1999-05-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075241-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1999-05-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A075241-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1999-05-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075241-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1999-05-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075241-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1999-05-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075241-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1999-05-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075241-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1999-05-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075241-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1999-05-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075241-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1999-05-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075241-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1999-05-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075241-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1999-05-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075241-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1999-05-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075241-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1999-05-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075241-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1999-05-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075241-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1999-05-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075241-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1999-05-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075241-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1999-05-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075241-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1999-05-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075241-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1999-05-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075241-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1999-05-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075241-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1999-05-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A075241-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1999-05-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075241-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1999-05-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075241-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1999-05-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075241-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1999-05-283f01610625f2…
2019-09-15 20:21 UTC2019-09A075241-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1999-05-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A075241-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1999-05-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075241-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1999-05-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075241-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1999-05-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075241-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1999-05-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075241-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1999-05-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075241-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1999-05-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075241-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1999-05-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075241-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1999-05-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A075241-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1999-05-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A075241-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1999-05-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075241-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1999-05-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075241-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1999-05-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075241-001FUROSEMIDE10MG/MLINJECTABLE / INJECTIONAP1999-05-28e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A075241-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075241-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075241-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075241-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075241-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075241-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075241-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075241-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075241-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075241-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075241-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075241-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075241-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075241-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075241-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075241-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075241-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075241-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075241-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075241-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075241-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075241-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A075241-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075241-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075241-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075241-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A075241-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075241-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075241-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075241-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075241-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075241-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075241-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075241-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075241-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A075241-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A075241-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075241-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075241-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075241-001AP1e64feba35796…

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 8 · 152 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FurosemideFUROSEMIDEREMEDYREPACK INC.dba00759-87b4-4ecf-998e-ba03ed3d2f1a2026-08-17Warnings, Adverse reactionsName fallback
brand name: Furosemide
generic name: FUROSEMIDE
FurosemideFUROSEMIDERedpharm Drug58d2a38d-75f8-dcb9-e063-6294a90a10d72026-08-12Warnings, Adverse reactionsName fallback
brand name: Furosemide
generic name: FUROSEMIDE
FurosemideFUROSEMIDEMedical Purchasing Solutions, LLC58cc1e38-6000-1489-e063-6394a90a59782026-08-11Warnings, Adverse reactionsName fallback
brand name: Furosemide
generic name: FUROSEMIDE
FUROSCIXFUROSEMIDE INJECTION 80 MG/ 10 MLscPharmaceuticals Inc., a wholly owned subsidiary of MannKind Corporationeac958dd-8d43-e44e-e053-2995a90a4d5e2026-07-31Warnings, 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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9861FurosemideFurosemideHenry Schein, IncANDACurrent
0404-9861FurosemideFurosemideHenry Schein, IncANDACurrent
0409-1639FurosemideFUROSEMIDEHospira, Inc.ANDACurrent
0409-1639FurosemideFUROSEMIDEHospira, Inc.ANDACurrent
0409-1639FurosemideFUROSEMIDEHospira, Inc.ANDACurrent
0409-1639FUROSEMIDEfurosemideHospira, Inc.ANDACurrent
0409-1639FurosemideFUROSEMIDEHospira, Inc.ANDACurrent
0409-1639FurosemideFUROSEMIDEHospira, Inc.ANDACurrent
0409-9631FurosemideFUROSEMIDEHospira, Inc.ANDACurrent
0409-9631FurosemideFUROSEMIDEHospira, Inc.ANDACurrent
0409-9631FurosemideFUROSEMIDEHospira, Inc.ANDACurrent
0409-9631FUROSEMIDEfurosemideHospira, Inc.ANDACurrent
0409-9631FurosemideFUROSEMIDEHospira, Inc.ANDACurrent
0409-9631FurosemideFUROSEMIDEHospira, Inc.ANDACurrent
52584-052FurosemideFurosemideGeneral Injectables & Vaccines, Inc.ANDACurrent
52584-052FurosemideFurosemideGeneral Injectables & Vaccines, Inc.ANDACurrent
52584-052FurosemideFurosemideGeneral Injectables & Vaccines, Inc.ANDACurrent
52584-052FurosemideFurosemideGeneral Injectables & Vaccines, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
39468ORIG1999-05-28
30811ORIG1999-05-28
22443ORIG1999-05-28