Application 090656

Type: ANDA
Sponsor: AM REGENT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TORSEMIDE	TORSEMIDE	INJECTABLE;INJECTION	20MG/2ML (10MG/ML)	No	No
002	TORSEMIDE	TORSEMIDE	INJECTABLE;INJECTION	50MG/5ML (10MG/ML)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090656-001	TORSEMIDE	TORSEMIDE	20MG/2ML (10MG/ML)	SOLUTION / INTRAVENOUS			2010-04-21
A090656-002	TORSEMIDE	TORSEMIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS			2010-04-21

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A090656-001	TORSEMIDE	20MG/2ML (10MG/ML)	SOLUTION / INTRAVENOUS	2010-04-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090656-002	TORSEMIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	2010-04-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090656-001	TORSEMIDE	20MG/2ML (10MG/ML)	SOLUTION / INTRAVENOUS	2010-04-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090656-002	TORSEMIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	2010-04-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090656-001	TORSEMIDE	20MG/2ML (10MG/ML)	SOLUTION / INTRAVENOUS	2010-04-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090656-002	TORSEMIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	2010-04-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090656-001	TORSEMIDE	20MG/2ML (10MG/ML)	SOLUTION / INTRAVENOUS	2010-04-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090656-002	TORSEMIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	2010-04-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090656-001	TORSEMIDE	20MG/2ML (10MG/ML)	SOLUTION / INTRAVENOUS	2010-04-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090656-002	TORSEMIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	2010-04-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090656-001	TORSEMIDE	20MG/2ML (10MG/ML)	SOLUTION / INTRAVENOUS	2010-04-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090656-002	TORSEMIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	2010-04-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090656-001	TORSEMIDE	20MG/2ML (10MG/ML)	SOLUTION / INTRAVENOUS	2010-04-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090656-002	TORSEMIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	2010-04-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090656-001	TORSEMIDE	20MG/2ML (10MG/ML)	SOLUTION / INTRAVENOUS	2010-04-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090656-002	TORSEMIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	2010-04-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090656-001	TORSEMIDE	20MG/2ML (10MG/ML)	SOLUTION / INTRAVENOUS	2010-04-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090656-002	TORSEMIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	2010-04-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090656-001	TORSEMIDE	20MG/2ML (10MG/ML)	SOLUTION / INTRAVENOUS	2010-04-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090656-002	TORSEMIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	2010-04-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090656-001	TORSEMIDE	20MG/2ML (10MG/ML)	SOLUTION / INTRAVENOUS	2010-04-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090656-002	TORSEMIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	2010-04-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090656-001	TORSEMIDE	20MG/2ML (10MG/ML)	SOLUTION / INTRAVENOUS	2010-04-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090656-002	TORSEMIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	2010-04-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090656-001	TORSEMIDE	20MG/2ML (10MG/ML)	SOLUTION / INTRAVENOUS	2010-04-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090656-002	TORSEMIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	2010-04-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090656-001	TORSEMIDE	20MG/2ML (10MG/ML)	SOLUTION / INTRAVENOUS	2010-04-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090656-002	TORSEMIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	2010-04-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090656-001	TORSEMIDE	20MG/2ML (10MG/ML)	SOLUTION / INTRAVENOUS	2010-04-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090656-002	TORSEMIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	2010-04-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090656-001	TORSEMIDE	20MG/2ML (10MG/ML)	SOLUTION / INTRAVENOUS	2010-04-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090656-002	TORSEMIDE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	2010-04-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090656-001	TORSEMIDE	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090656-002	TORSEMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090656-001	TORSEMIDE	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090656-002	TORSEMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090656-001	TORSEMIDE	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090656-002	TORSEMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090656-001	TORSEMIDE	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090656-002	TORSEMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`74a2ff9319b5…`

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 · 33 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Torsemide	TORSEMIDE	Aurobindo Pharma Limited	55e88727-864e-4313-860c-31a6ca45168f	2024-05-08	Warnings, Adverse reactions	Name fallback brand name: Torsemide generic name: TORSEMIDE
Torsemide	TORSEMIDE	Rising Pharma Holdings, Inc.	3c8f1c0b-8a44-4ca0-b2cf-3c591f8878fd	2024-05-08	Warnings, Adverse reactions	Name fallback brand name: Torsemide generic name: TORSEMIDE
Torsemide	TORSEMIDE	Aphena Pharma Solutions - Tennessee, LLC	159e8c90-ebc6-0991-e063-6394a90aae19	2024-04-08	Warnings, Adverse reactions	Name fallback brand name: Torsemide generic name: TORSEMIDE
Torsemide	TORSEMIDE	Golden State Medical Supply, Inc.	a6055317-8826-df85-e053-2a95a90a5378	2023-12-28	Warnings, Adverse reactions	Name fallback brand name: Torsemide generic name: TORSEMIDE
Torsemide	TORSEMIDE	Hikma Pharmaceuticals USA Inc.	fde1d1be-0faa-440a-9039-bdb103288c76	2023-08-31	Warnings, Adverse reactions	Name fallback brand name: Torsemide generic name: TORSEMIDE
Torsemide	TORSEMIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	03fbbb85-4e0f-4f3b-b4b0-87f84cb33d47	2023-06-30	Warnings, Adverse reactions	Name fallback brand name: Torsemide generic name: TORSEMIDE
Torsemide	TORSEMIDE	A-S Medication Solutions	3e9c6ee1-c49f-4f59-9391-8a9b57becb02	2023-05-25	Warnings, Adverse reactions	Name fallback brand name: Torsemide generic name: TORSEMIDE
Torsemide	TORSEMIDE	A-S Medication Solutions	3ed913ba-f0c0-4ba5-9440-73c4374f4226	2023-05-25	Warnings, Adverse reactions	Name fallback brand name: Torsemide generic name: TORSEMIDE
Torsemide	TORSEMIDE	Bryant Ranch Prepack	f24151c8-02cd-4b07-a7fd-796903210aba	2023-05-23	Warnings, Adverse reactions	Name fallback brand name: Torsemide generic name: TORSEMIDE
Torsemide	TORSEMIDE	NCS HealthCare of KY, LLC dba Vangard Labs	201e892d-d963-4c6a-b35b-c5780b01f659	2022-12-15	Warnings, Adverse reactions	Name fallback brand name: Torsemide generic name: TORSEMIDE
Torsemide	TORSEMIDE	Aphena Pharma Solutions - Tennessee, LLC	b869bc45-1ebb-42fb-82c5-603f09835790	2017-10-19	Warnings, Adverse reactions	Name fallback brand name: Torsemide generic name: TORSEMIDE
Torsemide	TORSEMIDE	Camber Pharmaceuticals, Inc.	0d4a4ef9-0944-452c-b014-bd822bfb9dd9	2017-08-14	Warnings, Adverse reactions	Name fallback brand name: Torsemide generic name: TORSEMIDE
Torsemide	TORSEMIDE	Teva Pharmaceuticals USA, Inc.	8a95cbdb-0601-47a5-9b3a-0c3b0629ceb9	2017-02-28	Warnings, Adverse reactions	Name fallback brand name: Torsemide generic name: TORSEMIDE

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 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0517-0770	Torsemide	Torsemide	American Regent, Inc.	ANDA	Current
0517-0770	Torsemide	Torsemide	American Regent, Inc.	ANDA	Current
0517-0771	Torsemide	Torsemide	American Regent, Inc.	ANDA	Current
0517-0771	Torsemide	Torsemide	American Regent, Inc.	ANDA	Current