Application 077293

Type
ANDA
Sponsor
LEADING PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FUROSEMIDEFUROSEMIDETABLET;ORAL20MGNoNo
002FUROSEMIDEFUROSEMIDETABLET;ORAL40MGNoNo
003FUROSEMIDEFUROSEMIDETABLET;ORAL80MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077293-001FUROSEMIDEFUROSEMIDE20MGTABLET / ORALAB2005-11-09
A077293-002FUROSEMIDEFUROSEMIDE40MGTABLET / ORALAB2005-11-09
A077293-003FUROSEMIDEFUROSEMIDE80MGTABLET / ORALAB2005-11-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A077293-001AB
A077293-002AB
A077293-003AB

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 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A077293-001FUROSEMIDE20MGTABLET / ORALAB2005-11-09c2088c7a36db…
2026-10-15 13:18:302026-09A077293-002FUROSEMIDE40MGTABLET / ORALAB2005-11-09c2088c7a36db…
2026-10-15 13:18:302026-09A077293-003FUROSEMIDE80MGTABLET / ORALAB2005-11-09c2088c7a36db…
2026-09-14 22:38:342026-08A077293-001FUROSEMIDE20MGTABLET / ORALAB2005-11-0984e616aacf4f…
2026-09-14 22:38:342026-08A077293-002FUROSEMIDE40MGTABLET / ORALAB2005-11-0984e616aacf4f…
2026-09-14 22:38:342026-08A077293-003FUROSEMIDE80MGTABLET / ORALAB2005-11-0984e616aacf4f…
2026-08-18 06:07:402026-07A077293-001FUROSEMIDE20MGTABLET / ORALAB2005-11-09caaa826d4ba7…
2026-08-18 06:07:402026-07A077293-002FUROSEMIDE40MGTABLET / ORALAB2005-11-09caaa826d4ba7…
2026-08-18 06:07:402026-07A077293-003FUROSEMIDE80MGTABLET / ORALAB2005-11-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077293-001FUROSEMIDE20MGTABLET / ORALAB2005-11-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077293-002FUROSEMIDE40MGTABLET / ORALAB2005-11-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077293-003FUROSEMIDE80MGTABLET / ORALAB2005-11-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077293-001FUROSEMIDE20MGTABLET / ORALAB2005-11-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077293-002FUROSEMIDE40MGTABLET / ORALAB2005-11-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077293-003FUROSEMIDE80MGTABLET / ORALAB2005-11-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A077293-001FUROSEMIDE20MGTABLET / ORALAB2005-11-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077293-002FUROSEMIDE40MGTABLET / ORALAB2005-11-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077293-003FUROSEMIDE80MGTABLET / ORALAB2005-11-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077293-001FUROSEMIDE20MGTABLET / ORALAB2005-11-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077293-002FUROSEMIDE40MGTABLET / ORALAB2005-11-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077293-003FUROSEMIDE80MGTABLET / ORALAB2005-11-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077293-001FUROSEMIDE20MGTABLET / ORALAB2005-11-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077293-002FUROSEMIDE40MGTABLET / ORALAB2005-11-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077293-003FUROSEMIDE80MGTABLET / ORALAB2005-11-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077293-001FUROSEMIDE20MGTABLET / ORALAB2005-11-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077293-002FUROSEMIDE40MGTABLET / ORALAB2005-11-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077293-003FUROSEMIDE80MGTABLET / ORALAB2005-11-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077293-001FUROSEMIDE20MGTABLET / ORALAB2005-11-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077293-002FUROSEMIDE40MGTABLET / ORALAB2005-11-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077293-003FUROSEMIDE80MGTABLET / ORALAB2005-11-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077293-001FUROSEMIDE20MGTABLET / ORALAB2005-11-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077293-002FUROSEMIDE40MGTABLET / ORALAB2005-11-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077293-003FUROSEMIDE80MGTABLET / ORALAB2005-11-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077293-001FUROSEMIDE20MGTABLET / ORALAB2005-11-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077293-002FUROSEMIDE40MGTABLET / ORALAB2005-11-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077293-003FUROSEMIDE80MGTABLET / ORALAB2005-11-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077293-001FUROSEMIDE20MGTABLET / ORALAB2005-11-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A077293-002FUROSEMIDE40MGTABLET / ORALAB2005-11-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A077293-003FUROSEMIDE80MGTABLET / ORALAB2005-11-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077293-001FUROSEMIDE20MGTABLET / ORALAB2005-11-0979d66fd596c7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A077293-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A077293-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09A077293-003AB1c2088c7a36db…
2026-09-14 22:38:342026-08A077293-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A077293-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A077293-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A077293-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077293-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077293-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077293-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077293-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077293-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077293-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077293-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077293-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077293-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077293-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077293-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077293-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077293-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077293-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077293-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077293-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077293-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077293-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077293-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077293-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077293-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077293-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077293-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077293-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077293-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077293-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077293-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077293-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077293-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077293-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077293-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077293-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077293-001AB179d66fd596c7…

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 2 · 29 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FurosemideFUROSEMIDECalvin Scott & Co., Inc.b2cc89e5-6619-4113-ad31-48076652c8562024-04-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077293
application number: ANDA077293
FUROSEMIDEFUROSEMIDEDIRECT RX9ec7808e-9201-4b8c-9790-d329320dc6c42024-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077293
application number: ANDA077293
FurosemideFUROSEMIDEA-S Medication Solutions60cf5e60-9a7a-42c2-95b5-016f7a68ffc42023-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077293
application number: ANDA077293
FurosemideFUROSEMIDEA-S Medication Solutions25171259-dcf1-4984-9581-cd69dee8dffb2023-04-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077293
application number: ANDA077293
FurosemideFUROSEMIDECalvin Scott & Co., Inc.43be0231-0d88-4a21-b2ab-793155cbddb22023-03-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077293
application number: ANDA077293
FurosemideFUROSEMIDEA-S Medication Solutions52f0c9d5-396f-4033-abe8-145eec3e69832023-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077293
application number: ANDA077293
FurosemideFUROSEMIDEProficient Rx LP595ddaf2-c2cb-44a4-a46c-53bcfe6bd7522022-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077293
application number: ANDA077293
FurosemideFUROSEMIDELeading Pharma, LLCb5c6fcf4-fd37-4fee-8dac-1a3273d95ffe2022-11-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077293
application number: ANDA077293
ndc (product): 69315-116
ndc (product): 69315-118
ndc (product): 69315-117
FurosemideFUROSEMIDEProficient Rx LPce84359c-2f76-421a-9b2b-79b1c2be2f202021-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077293
application number: ANDA077293

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 158 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68071-1809FurosemideFurosemideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1809FurosemideFurosemideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3148FurosemideFurosemideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3194FurosemideFurosemideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3194FurosemideFurosemideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3273FurosemideFurosemideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3273FurosemideFurosemideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3273FurosemideFurosemideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4022FurosemideFurosemideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4022FurosemideFurosemideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4022FurosemideFurosemideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4022FurosemideFurosemideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-6367LasixFurosemidePreferred Pharmaceuticals Inc.ANDACurrent
68788-6397FurosemideFurosemidePreferred Pharmaceuticals Inc.ANDACurrent
68788-6784FurosemideFurosemidePreferred Pharmaceuticals, Inc.ANDACurrent
68788-6784FurosemideFurosemidePreferred Pharmaceuticals, Inc.ANDACurrent
68788-6784FurosemideFurosemidePreferred Pharmaceuticals, Inc.ANDACurrent
68788-6784FurosemideFurosemidePreferred Pharmaceuticals, Inc.ANDACurrent
68788-6784FurosemideFurosemidePreferred Pharmaceuticals, Inc.ANDACurrent
68788-6948FurosemideFurosemidePreferred Pharmaceuticals Inc.ANDACurrent
68788-6948FurosemideFurosemidePreferred Pharmaceuticals Inc.ANDACurrent
68788-6948FurosemideFurosemidePreferred Pharmaceuticals Inc.ANDACurrent
68788-6948FurosemideFurosemidePreferred Pharmaceuticals Inc.ANDACurrent
68788-6948FurosemideFurosemidePreferred Pharmaceuticals Inc.ANDACurrent
69315-116FurosemideFurosemideLeading Pharma, LLCANDACurrent
69315-116FurosemideFurosemideLeading Pharma, LLCANDACurrent
69315-116FurosemideFurosemideLeading Pharma, LLCANDACurrent
69315-116FurosemideFurosemideLeading Pharma, LLCANDACurrent
69315-117FurosemideFurosemideLeading Pharma, LLCANDACurrent
69315-117FurosemideFurosemideLeading Pharma, LLCANDACurrent
69315-117FurosemideFurosemideLeading Pharma, LLCANDACurrent
69315-117FurosemideFurosemideLeading Pharma, LLCANDACurrent
69315-118FurosemideFurosemideLeading Pharma, LLCANDACurrent
69315-118FurosemideFurosemideLeading Pharma, LLCANDACurrent
69315-118FurosemideFurosemideLeading Pharma, LLCANDACurrent
69315-118FurosemideFurosemideLeading Pharma, LLCANDACurrent
69677-204FurosemideFurosemideMas Management Group, Inc.ANDACurrent
70518-0050FurosemideFurosemideREMEDYREPACK INC.ANDACurrent
70518-0050FurosemideFurosemideREMEDYREPACK INC.ANDACurrent
70518-0050FurosemideFurosemideREMEDYREPACK INC.ANDACurrent
70518-0050FurosemideFurosemideREMEDYREPACK INC.ANDACurrent
70518-0050FurosemideFurosemideREMEDYREPACK INC.ANDACurrent
70518-0050FurosemideFurosemideREMEDYREPACK INC.ANDACurrent
70518-0050FurosemideFurosemideREMEDYREPACK INC.ANDACurrent
70518-0050FurosemideFurosemideREMEDYREPACK INC.ANDACurrent
70518-0251FurosemideFurosemideREMEDYREPACK INC.ANDACurrent
70518-0251FurosemideFurosemideREMEDYREPACK INC.ANDACurrent
70518-0251FurosemideFurosemideREMEDYREPACK INC.ANDACurrent
70518-0251FurosemideFurosemideREMEDYREPACK INC.ANDACurrent
70518-0251FurosemideFurosemideREMEDYREPACK INC.ANDACurrent
70518-0251FurosemideFurosemideREMEDYREPACK INC.ANDACurrent
70518-0251FurosemideFurosemideREMEDYREPACK INC.ANDACurrent
70518-0251FurosemideFurosemideREMEDYREPACK INC.ANDACurrent
70518-0251FurosemideFurosemideREMEDYREPACK INC.ANDACurrent
70518-0581FurosemideFurosemideREMEDYREPACK INC.ANDACurrent
70518-0581FurosemideFurosemideREMEDYREPACK INC.ANDACurrent
70518-2528FurosemideFurosemideREMEDYREPACK INC.ANDACurrent
70529-061FurosemideFurosemideIT3 Medical LLCANDACurrent
70529-061FurosemideFurosemideIT3 Medical LLCANDACurrent
70529-061FurosemideFurosemideIT3 Medical LLCANDACurrent
70529-062FurosemideFurosemideIT3 Medical LLCANDACurrent
70529-062FurosemideFurosemideIT3 Medical LLCANDACurrent
70529-062FurosemideFurosemideIT3 Medical LLCANDACurrent
70529-549TOXYCOLOGY Medicated Collection SystemFurosemideIT3 Medical LLCANDACurrent
70529-549TOXYCOLOGY Medicated Collection SystemFurosemideIT3 Medical LLCANDACurrent
70529-549TOXYCOLOGY Medicated Collection SystemFurosemideIT3 Medical LLCANDACurrent
70529-550Diascreen 12-Panel Medicated Collection SystemFurosemideIT3 Medical LLCANDACurrent
70529-550Diascreen 12-Panel Medicated Collection SystemFurosemideIT3 Medical LLCANDACurrent
70529-550Diascreen 12-Panel Medicated Collection SystemFurosemideIT3 Medical LLCANDACurrent
70934-111FurosemideFurosemideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-111FurosemideFurosemideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-111FurosemideFurosemideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0129FurosemideFurosemideBryant Ranch PrepackANDACurrent
71335-0129FurosemideFurosemideBryant Ranch PrepackANDACurrent
71335-0129FurosemideFurosemideBryant Ranch PrepackANDACurrent
71335-0384FurosemideFurosemideBryant Ranch PrepackANDACurrent
71335-0384FurosemideFurosemideBryant Ranch PrepackANDACurrent
71335-0384FurosemideFurosemideBryant Ranch PrepackANDACurrent