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 2 of 2 · 31 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FurosemideFUROSEMIDEBryant Ranch Prepackd07ff11c-c1ab-41e6-a455-f2b89340106e2024-02-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796
FurosemideFUROSEMIDEBryant Ranch Prepacka5e94bf3-bb18-4c81-98af-8c1cb7e004962024-02-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796
FUROSEMIDEFUROSEMIDEDIRECT RX9ec7808e-9201-4b8c-9790-d329320dc6c42024-01-09Warnings, Adverse reactionsExact identifier
ndc (product): 61919-442
FurosemideFUROSEMIDEBryant Ranch Prepack020bc039-9e99-4895-96f8-0c6a556d3e672023-10-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796
FurosemideFUROSEMIDEBryant Ranch Prepack01a5f094-b473-4e46-9e61-69d5ec6dd7662023-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796
ndc (product): 63629-1120
FurosemideFUROSEMIDEBryant Ranch Prepack6820724c-1ca5-451c-9d2b-2d38e60036f52023-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796
ndc (product): 63629-1217
FurosemideFUROSEMIDEBryant Ranch Prepack440aaaed-47df-4bb5-8b41-2c80568936792023-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796
ndc (product): 63629-1216
FurosemideFUROSEMIDEBryant Ranch Prepack15ae6f44-88dd-4455-b1f7-4718c91e7b662023-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796
ndc (product): 63629-1119
FurosemideFUROSEMIDEBryant Ranch Prepack3ad12e70-3c2e-44af-bb6b-5762d181c76b2023-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796
ndc (product): 63629-1214
FurosemideFUROSEMIDEAphena Pharma Solutions - Tennessee, LLC6f124d7d-a19d-4de6-8ea4-719a42eb520b2022-03-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076796
application number: ANDA076796
FurosemideFUROSEMIDEAphena Pharma Solutions - Tennessee, LLC1d2733ac-6fa6-44d1-96d4-f1a698045ad22018-04-18Warnings, 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 1 of 2 · 136 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8368FurosemidefurosemideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8368FurosemidefurosemideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8368FurosemidefurosemideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8369FurosemidefurosemideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8369FurosemidefurosemideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8369FurosemidefurosemideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8370FurosemidefurosemideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8370FurosemidefurosemideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8370FurosemidefurosemideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0904-7177FurosemidefurosemideMajor PharmaceuticalsANDACurrent
0904-7178FurosemidefurosemideMajor PharmaceuticalsANDACurrent
35356-873FurosemidefurosemideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-920FurosemidefurosemideLake Erie Medical DBA Quality Care Products LLCANDACurrent
42291-468FurosemidefurosemideAvKAREANDACurrent
42291-469FurosemidefurosemideAvKAREANDACurrent
42291-470FurosemidefurosemideAvKAREANDACurrent
42708-026FurosemidefurosemideQPharma IncANDACurrent
42708-026FurosemidefurosemideQPharma IncANDACurrent
43063-849FurosemidefurosemidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-849FurosemidefurosemidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-849FurosemidefurosemidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-849FurosemidefurosemidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-849FurosemidefurosemidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-849FurosemidefurosemidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-849FurosemidefurosemidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43547-401FurosemidefurosemideSolco Healthcare LLCANDACurrent
43547-401FurosemidefurosemideSolco Healthcare LLCANDACurrent
43547-401FurosemidefurosemideSolco Healthcare LLCANDACurrent
43547-402FurosemidefurosemideSolco Healthcare LLCANDACurrent
43547-402FurosemidefurosemideSolco Healthcare LLCANDACurrent
43547-402FurosemidefurosemideSolco Healthcare LLCANDACurrent
43547-403FurosemidefurosemideSolco Healthcare LLCANDACurrent
43547-403FurosemidefurosemideSolco Healthcare LLCANDACurrent
43547-403FurosemidefurosemideSolco Healthcare LLCANDACurrent
50090-3338FurosemidefurosemideA-S Medication SolutionsANDACurrent
50090-3338FurosemidefurosemideA-S Medication SolutionsANDACurrent
50090-3338FurosemidefurosemideA-S Medication SolutionsANDACurrent
50090-3339FurosemidefurosemideA-S Medication SolutionsANDACurrent
50090-3339FurosemidefurosemideA-S Medication SolutionsANDACurrent
50090-3339FurosemidefurosemideA-S Medication SolutionsANDACurrent
50090-3455FurosemidefurosemideA-S Medication SolutionsANDACurrent
50090-3455FurosemidefurosemideA-S Medication SolutionsANDACurrent
50090-3488FurosemidefurosemideA-S Medication SolutionsANDACurrent
50090-3488FurosemidefurosemideA-S Medication SolutionsANDACurrent
50090-3488FurosemidefurosemideA-S Medication SolutionsANDACurrent
53808-1109FurosemidefurosemideDOH CENTRAL PHARMACYANDACurrent
60760-707FurosemidefurosemideSt. Mary's Medical Park PharmacyANDACurrent
60760-708FurosemidefurosemideSt Mary's Medical Park PharmacyANDACurrent
61919-284FUROSEMIDEFUROSEMIDEDIRECT RXANDACurrent
61919-442FUROSEMIDEFUROSEMIDEDIRECT RXANDACurrent
61919-442FUROSEMIDEFUROSEMIDEDIRECT RXANDACurrent
61919-442FUROSEMIDEFUROSEMIDEDIRECT RXANDACurrent
61919-442FUROSEMIDEFUROSEMIDEDIRECT RXANDACurrent
63629-1119FurosemidefurosemideBryant Ranch PrepackANDACurrent
63629-1119FurosemidefurosemideBryant Ranch PrepackANDACurrent
63629-1120FurosemidefurosemideBryant Ranch PrepackANDACurrent
63629-1120FurosemidefurosemideBryant Ranch PrepackANDACurrent
63629-1214FurosemidefurosemideBryant Ranch PrepackANDACurrent
63629-1214FurosemidefurosemideBryant Ranch PrepackANDACurrent
63629-1215FurosemidefurosemideBryant Ranch PrepackANDACurrent
63629-1215FurosemidefurosemideBryant Ranch PrepackANDACurrent
63629-1216FurosemidefurosemideBryant Ranch PrepackANDACurrent
63629-1216FurosemidefurosemideBryant Ranch PrepackANDACurrent
63629-1217FurosemidefurosemideBryant Ranch PrepackANDACurrent
63629-1217FurosemidefurosemideBryant Ranch PrepackANDACurrent
63629-8058FurosemidefurosemideBryant Ranch PrepackANDACurrent
63629-8058FurosemidefurosemideBryant Ranch PrepackANDACurrent
64205-739FurosemidefurosemideReadyMedsANDACurrent
64205-740FurosemidefurosemideReadyMedsANDACurrent
67296-1665FurosemidefurosemideRedPharm Drug, Inc.ANDACurrent
67296-1665FurosemidefurosemideRedPharm Drug, Inc.ANDACurrent
67296-1665FurosemidefurosemideRedPharm Drug, Inc.ANDACurrent
67296-1665FurosemidefurosemideRedPharm Drug, Inc.ANDACurrent
68071-2313FurosemidefurosemideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2313FurosemidefurosemideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2360FurosemidefurosemideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2461FurosemidefurosemideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4349FurosemidefurosemideNuCare Pharmaceuticals,InANDACurrent
68071-4349FurosemidefurosemideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4349FurosemidefurosemideNuCare Pharmaceuticals,Inc.ANDACurrent