Application 076796

Type
ANDA
Sponsor
PRINSTON INC

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 43.

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
A076796-001FUROSEMIDEFUROSEMIDE20MGTABLET / ORALAB2004-03-26
A076796-002FUROSEMIDEFUROSEMIDE40MGTABLET / ORALAB2004-03-26
A076796-003FUROSEMIDEFUROSEMIDE80MGTABLET / ORALAB2004-03-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076796-001AB
A076796-002AB
A076796-003AB

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076796-001FUROSEMIDE20MGTABLET / ORALAB2004-03-2684e616aacf4f…
2026-09-14 22:38:342026-08A076796-002FUROSEMIDE40MGTABLET / ORALAB2004-03-2684e616aacf4f…
2026-09-14 22:38:342026-08A076796-003FUROSEMIDE80MGTABLET / ORALAB2004-03-2684e616aacf4f…
2026-08-18 06:07:402026-07A076796-001FUROSEMIDE20MGTABLET / ORALAB2004-03-26caaa826d4ba7…
2026-08-18 06:07:402026-07A076796-002FUROSEMIDE40MGTABLET / ORALAB2004-03-26caaa826d4ba7…
2026-08-18 06:07:402026-07A076796-003FUROSEMIDE80MGTABLET / ORALAB2004-03-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076796-001FUROSEMIDE20MGTABLET / ORALAB2004-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076796-002FUROSEMIDE40MGTABLET / ORALAB2004-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076796-003FUROSEMIDE80MGTABLET / ORALAB2004-03-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076796-001FUROSEMIDE20MGTABLET / ORALAB2004-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076796-002FUROSEMIDE40MGTABLET / ORALAB2004-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076796-003FUROSEMIDE80MGTABLET / ORALAB2004-03-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A076796-001FUROSEMIDE20MGTABLET / ORALAB2004-03-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076796-002FUROSEMIDE40MGTABLET / ORALAB2004-03-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076796-003FUROSEMIDE80MGTABLET / ORALAB2004-03-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076796-001FUROSEMIDE20MGTABLET / ORALAB2004-03-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076796-002FUROSEMIDE40MGTABLET / ORALAB2004-03-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076796-003FUROSEMIDE80MGTABLET / ORALAB2004-03-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076796-001FUROSEMIDE20MGTABLET / ORALAB2004-03-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076796-002FUROSEMIDE40MGTABLET / ORALAB2004-03-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076796-003FUROSEMIDE80MGTABLET / ORALAB2004-03-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076796-001FUROSEMIDE20MGTABLET / ORALAB2004-03-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076796-002FUROSEMIDE40MGTABLET / ORALAB2004-03-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076796-003FUROSEMIDE80MGTABLET / ORALAB2004-03-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076796-001FUROSEMIDE20MGTABLET / ORALAB2004-03-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076796-002FUROSEMIDE40MGTABLET / ORALAB2004-03-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076796-003FUROSEMIDE80MGTABLET / ORALAB2004-03-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076796-001FUROSEMIDE20MGTABLET / ORALAB2004-03-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076796-002FUROSEMIDE40MGTABLET / ORALAB2004-03-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076796-003FUROSEMIDE80MGTABLET / ORALAB2004-03-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076796-001FUROSEMIDE20MGTABLET / ORALAB2004-03-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076796-002FUROSEMIDE40MGTABLET / ORALAB2004-03-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076796-003FUROSEMIDE80MGTABLET / ORALAB2004-03-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076796-001FUROSEMIDE20MGTABLET / ORALAB2004-03-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A076796-002FUROSEMIDE40MGTABLET / ORALAB2004-03-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A076796-003FUROSEMIDE80MGTABLET / ORALAB2004-03-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076796-001FUROSEMIDE20MGTABLET / ORALAB2004-03-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076796-002FUROSEMIDE40MGTABLET / ORALAB2004-03-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076796-003FUROSEMIDE80MGTABLET / ORALAB2004-03-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076796-001FUROSEMIDE20MGTABLET / ORALAB2004-03-26301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A076796-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A076796-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A076796-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A076796-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076796-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076796-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076796-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076796-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076796-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076796-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076796-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076796-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076796-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076796-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076796-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076796-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076796-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076796-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076796-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076796-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076796-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076796-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076796-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076796-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076796-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076796-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076796-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076796-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076796-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076796-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076796-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076796-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076796-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076796-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076796-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076796-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076796-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076796-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076796-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076796-001AB1301d65b070ca…

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 2 · 30 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FurosemideFUROSEMIDEREMEDYREPACK INC.3d312ab0-589c-427b-84da-18887244bfc92026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796
ndc (product): 70518-3061
FurosemideFUROSEMIDECardinal Health 107, LLC2a5bcf50-6d63-463a-915e-a72ea2e5f1312026-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796
FurosemideFUROSEMIDEMajor Pharmaceuticals6be1addd-a811-47fc-8650-6870d661c2342026-05-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796
FurosemideFUROSEMIDEREMEDYREPACK INC.7181e528-c862-4dd7-8446-9011e4c7312a2026-04-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796
FurosemideFUROSEMIDENuCare Pharmaceuticals,Inc.bd45c963-a413-e9a1-e053-2a95a90a14382026-02-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796
FurosemideFUROSEMIDEAvKAREd4c532be-1f3f-60d3-e053-2995a90a98be2026-01-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796
FurosemideFUROSEMIDENorthwind Health Company, LLCf2b920b2-f8b3-1e6e-e053-2a95a90ae1532026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796
FurosemideFUROSEMIDEPD-Rx Pharmaceuticals, Inc.48d8f490-e9d1-4c95-ab2f-414d3f4a9df42025-08-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796
ndc (product): 72789-157
FurosemideFUROSEMIDEPD-Rx Pharmaceuticals, Inc.c24489c3-65e0-44e3-a50a-8bb0672e88212025-08-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796
ndc (product): 72789-030
FurosemideFUROSEMIDEPD-Rx Pharmaceuticals, Inc.52e75604-5766-40e8-a13a-8c449e06ebda2025-08-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796
ndc (product): 72789-032
FurosemideFUROSEMIDEPD-Rx Pharmaceuticals, Inc.12137a90-fb35-45d7-8984-0b04793d3e342025-08-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796
ndc (product): 72789-033
FurosemideFUROSEMIDEPD-Rx Pharmaceuticals, Inc.3ba730ab-90d4-478a-80b3-1ea3edb03e4d2025-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796
FurosemideFUROSEMIDESolco Healthcare LLC6a0fb397-63ae-4fce-bddf-16a91b1b7a2f2025-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796
FurosemideFUROSEMIDENCS HealthCare of KY, LLC dba Vangard Labs114f4f4f-536a-4658-8fd0-2dd8c029b19a2024-09-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796
FurosemideFUROSEMIDEBryant Ranch Prepack25c0aded-ffcd-4145-a48c-76c5fb220f612024-08-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796
ndc (product): 71335-0852
ndc (product): 71335-0842
FurosemideFUROSEMIDENuCare Pharmaceuticals,Inc.6cbf3834-0433-4dc0-e053-2a91aa0a8f8a2024-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796
ndc (product): 68071-4445
FurosemideFUROSEMIDENuCare Pharmaceuticals,Inc.7316929d-413a-e78f-e053-2a91aa0a417e2024-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796
ndc (product): 68071-4522
FurosemideFUROSEMIDENuCare Pharmaceuticals,Inc.73e5c8f3-32f8-114c-e053-2a91aa0ab5002024-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796
ndc (product): 68071-4534
FurosemideFUROSEMIDEAphena Pharma Solutions - Tennessee, LLC4b3e2e13-a657-4da5-b536-8ae0a26812e02024-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796
ndc (product): 71610-096
FurosemideFUROSEMIDEBryant Ranch Prepack3b028a3c-102a-40f1-820e-b187ff1e18032024-03-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796

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 · 136 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68071-4445FurosemidefurosemideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4445FurosemidefurosemideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4445FurosemidefurosemideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4522FurosemidefurosemideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4522FurosemidefurosemideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4534FurosemidefurosemideNuCare Pharmaceuticals,InANDACurrent
68071-4534FurosemidefurosemideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4534FurosemidefurosemideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7265FurosemidefurosemidePreferred Pharmaceuticals Inc.ANDACurrent
68788-7265FurosemidefurosemidePreferred Pharmaceuticals Inc.ANDACurrent
68788-7265FurosemidefurosemidePreferred Pharmaceuticals Inc.ANDACurrent
68788-7265FurosemidefurosemidePreferred Pharmaceuticals Inc.ANDACurrent
68788-7265FurosemidefurosemidePreferred Pharmaceuticals Inc.ANDACurrent
68788-7354FurosemidefurosemidePreferred Pharmaceuticals Inc.ANDACurrent
68788-7354FurosemidefurosemidePreferred Pharmaceuticals Inc.ANDACurrent
68788-7354FurosemidefurosemidePreferred Pharmaceuticals Inc.ANDACurrent
68788-7354FurosemidefurosemidePreferred Pharmaceuticals Inc.ANDACurrent
68788-7354FurosemidefurosemidePreferred Pharmaceuticals Inc.ANDACurrent
70518-0092FurosemidefurosemideREMEDYREPACK INC.ANDACurrent
70518-2766FurosemidefurosemideREMEDYREPACK INC.ANDACurrent
70518-2766FurosemidefurosemideREMEDYREPACK INC.ANDACurrent
70518-3061FurosemidefurosemideREMEDYREPACK INC.ANDACurrent
70518-3061FurosemidefurosemideREMEDYREPACK INC.ANDACurrent
70518-3061FurosemidefurosemideREMEDYREPACK INC.ANDACurrent
70934-439FurosemidefurosemideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-439FurosemidefurosemideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0842FurosemidefurosemideBryant Ranch PrepackANDACurrent
71335-0842FurosemidefurosemideBryant Ranch PrepackANDACurrent
71335-0852FurosemidefurosemideBryant Ranch PrepackANDACurrent
71335-0852FurosemidefurosemideBryant Ranch PrepackANDACurrent
71335-0852FurosemidefurosemideBryant Ranch PrepackANDACurrent
71335-1683FurosemidefurosemideBryant Ranch PrepackANDACurrent
71610-049FurosemidefurosemideAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-096FurosemidefurosemideAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-634FurosemidefurosemideAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-634FurosemidefurosemideAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-635FurosemidefurosemideAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-635FurosemidefurosemideAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-636FurosemidefurosemideAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-636FurosemidefurosemideAphena Pharma Solutions - Tennessee, LLCANDACurrent
72789-030FurosemidefurosemidePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-030FurosemidefurosemidePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-030FurosemidefurosemidePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-030FurosemidefurosemidePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-032FurosemidefurosemidePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-032FurosemidefurosemidePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-032FurosemidefurosemidePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-032FurosemidefurosemidePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-033FurosemidefurosemidePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-033FurosemidefurosemidePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-033FurosemidefurosemidePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-033FurosemidefurosemidePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-033FurosemidefurosemidePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-033FurosemidefurosemidePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-157FurosemidefurosemidePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-157FurosemidefurosemidePD-Rx Pharmaceuticals, Inc.ANDACurrent