Application 076796

Type: ANDA
Sponsor: PRINSTON INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FUROSEMIDE	FUROSEMIDE	TABLET;ORAL	20MG	No	No
002	FUROSEMIDE	FUROSEMIDE	TABLET;ORAL	40MG	No	No
003	FUROSEMIDE	FUROSEMIDE	TABLET;ORAL	80MG	No	No

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A076796-001	FUROSEMIDE	FUROSEMIDE	20MG	TABLET / ORAL	AB	2004-03-26
A076796-002	FUROSEMIDE	FUROSEMIDE	40MG	TABLET / ORAL	AB	2004-03-26
A076796-003	FUROSEMIDE	FUROSEMIDE	80MG	TABLET / ORAL	AB	2004-03-26

Therapeutic equivalence codes#

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

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

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A076796-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2004-03-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A076796-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2004-03-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A076796-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2004-03-26	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A076796-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2004-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076796-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2004-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076796-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2004-03-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076796-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2004-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076796-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2004-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076796-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2004-03-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076796-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2004-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076796-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2004-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076796-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2004-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076796-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2004-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076796-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2004-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076796-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2004-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076796-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2004-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076796-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2004-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076796-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2004-03-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076796-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2004-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076796-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2004-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076796-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2004-03-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076796-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2004-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076796-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2004-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076796-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2004-03-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076796-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2004-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076796-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2004-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076796-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2004-03-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076796-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2004-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076796-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2004-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076796-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2004-03-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076796-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2004-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076796-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2004-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076796-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2004-03-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076796-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2004-03-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076796-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2004-03-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076796-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2004-03-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076796-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2004-03-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076796-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2004-03-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076796-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2004-03-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076796-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2004-03-26	`79d66fd596c7…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A076796-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A076796-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A076796-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A076796-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076796-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076796-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076796-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076796-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076796-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076796-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076796-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076796-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076796-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076796-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076796-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076796-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076796-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076796-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076796-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076796-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076796-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076796-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076796-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076796-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076796-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076796-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076796-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076796-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076796-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076796-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076796-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076796-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076796-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076796-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076796-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076796-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076796-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076796-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076796-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076796-001	AB	1	`79d66fd596c7…`

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 · 30 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Furosemide	FUROSEMIDE	Bryant Ranch Prepack	d07ff11c-c1ab-41e6-a455-f2b89340106e	2024-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076796 application number: ANDA076796
Furosemide	FUROSEMIDE	Bryant Ranch Prepack	a5e94bf3-bb18-4c81-98af-8c1cb7e00496	2024-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076796 application number: ANDA076796
Furosemide	FUROSEMIDE	Bryant Ranch Prepack	020bc039-9e99-4895-96f8-0c6a556d3e67	2023-10-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076796 application number: ANDA076796
Furosemide	FUROSEMIDE	Bryant Ranch Prepack	01a5f094-b473-4e46-9e61-69d5ec6dd766	2023-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076796 application number: ANDA076796
Furosemide	FUROSEMIDE	Bryant Ranch Prepack	6820724c-1ca5-451c-9d2b-2d38e60036f5	2023-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076796 application number: ANDA076796
Furosemide	FUROSEMIDE	Bryant Ranch Prepack	440aaaed-47df-4bb5-8b41-2c8056893679	2023-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076796 application number: ANDA076796
Furosemide	FUROSEMIDE	Bryant Ranch Prepack	15ae6f44-88dd-4455-b1f7-4718c91e7b66	2023-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076796 application number: ANDA076796
Furosemide	FUROSEMIDE	Bryant Ranch Prepack	3ad12e70-3c2e-44af-bb6b-5762d181c76b	2023-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076796 application number: ANDA076796
Furosemide	FUROSEMIDE	Aphena Pharma Solutions - Tennessee, LLC	6f124d7d-a19d-4de6-8ea4-719a42eb520b	2022-03-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076796 application number: ANDA076796 ndc (product): 71610-636 ndc (product): 71610-635 ndc (product): 71610-634
Furosemide	FUROSEMIDE	Aphena Pharma Solutions - Tennessee, LLC	1d2733ac-6fa6-44d1-96d4-f1a698045ad2	2018-04-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076796 application number: ANDA076796 ndc (product): 71610-049

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
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68071-4445	Furosemide	furosemide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4445	Furosemide	furosemide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4445	Furosemide	furosemide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4522	Furosemide	furosemide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4522	Furosemide	furosemide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4534	Furosemide	furosemide	NuCare Pharmaceuticals,In	ANDA	Current
68071-4534	Furosemide	furosemide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4534	Furosemide	furosemide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7265	Furosemide	furosemide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7265	Furosemide	furosemide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7265	Furosemide	furosemide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7265	Furosemide	furosemide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7265	Furosemide	furosemide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7354	Furosemide	furosemide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7354	Furosemide	furosemide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7354	Furosemide	furosemide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7354	Furosemide	furosemide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7354	Furosemide	furosemide	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-0092	Furosemide	furosemide	REMEDYREPACK INC.	ANDA	Current
70518-2766	Furosemide	furosemide	REMEDYREPACK INC.	ANDA	Current
70518-2766	Furosemide	furosemide	REMEDYREPACK INC.	ANDA	Current
70518-3061	Furosemide	furosemide	REMEDYREPACK INC.	ANDA	Current
70518-3061	Furosemide	furosemide	REMEDYREPACK INC.	ANDA	Current
70518-3061	Furosemide	furosemide	REMEDYREPACK INC.	ANDA	Current
70934-439	Furosemide	furosemide	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-439	Furosemide	furosemide	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71335-0842	Furosemide	furosemide	Bryant Ranch Prepack	ANDA	Current
71335-0842	Furosemide	furosemide	Bryant Ranch Prepack	ANDA	Current
71335-0852	Furosemide	furosemide	Bryant Ranch Prepack	ANDA	Current
71335-0852	Furosemide	furosemide	Bryant Ranch Prepack	ANDA	Current
71335-0852	Furosemide	furosemide	Bryant Ranch Prepack	ANDA	Current
71335-1683	Furosemide	furosemide	Bryant Ranch Prepack	ANDA	Current
71610-049	Furosemide	furosemide	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-096	Furosemide	furosemide	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-634	Furosemide	furosemide	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-634	Furosemide	furosemide	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-635	Furosemide	furosemide	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-635	Furosemide	furosemide	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-636	Furosemide	furosemide	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-636	Furosemide	furosemide	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
72789-030	Furosemide	furosemide	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-030	Furosemide	furosemide	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-030	Furosemide	furosemide	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-030	Furosemide	furosemide	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-032	Furosemide	furosemide	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-032	Furosemide	furosemide	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-032	Furosemide	furosemide	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-032	Furosemide	furosemide	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-033	Furosemide	furosemide	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-033	Furosemide	furosemide	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-033	Furosemide	furosemide	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-033	Furosemide	furosemide	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-033	Furosemide	furosemide	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-033	Furosemide	furosemide	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-157	Furosemide	furosemide	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-157	Furosemide	furosemide	PD-Rx Pharmaceuticals, Inc.	ANDA	Current