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 2 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
2022-03-09 01:35 UTC	2022-03	A090656-001	TORSEMIDE	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090656-002	TORSEMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090656-001	TORSEMIDE	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090656-002	TORSEMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090656-001	TORSEMIDE	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090656-002	TORSEMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090656-001	TORSEMIDE	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090656-002	TORSEMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090656-001	TORSEMIDE	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090656-002	TORSEMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090656-001	TORSEMIDE	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090656-002	TORSEMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090656-001	TORSEMIDE	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090656-002	TORSEMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090656-001	TORSEMIDE	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090656-002	TORSEMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090656-001	TORSEMIDE	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090656-002	TORSEMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090656-001	TORSEMIDE	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090656-002	TORSEMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090656-001	TORSEMIDE	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A090656-002	TORSEMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090656-001	TORSEMIDE	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A090656-002	TORSEMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090656-001	TORSEMIDE	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090656-002	TORSEMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090656-001	TORSEMIDE	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090656-002	TORSEMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090656-001	TORSEMIDE	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090656-002	TORSEMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090656-001	TORSEMIDE	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090656-002	TORSEMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090656-001	TORSEMIDE	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A090656-002	TORSEMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090656-001	TORSEMIDE	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A090656-002	TORSEMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090656-001	TORSEMIDE	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090656-002	TORSEMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090656-001	TORSEMIDE	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A090656-002	TORSEMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	2010-04-21	`f41ea6bd6efb…`

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 · 33 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Torsemide	TORSEMIDE	REMEDYREPACK INC.	26a3af16-39fc-482d-8a8e-9473af4b0e3f	2026-08-27	Warnings, Adverse reactions	Name fallback brand name: Torsemide generic name: TORSEMIDE
Torsemide	TORSEMIDE	REMEDYREPACK INC.	1c755d94-b846-4336-a968-aa1b92dc0ac0	2026-07-21	Warnings, Adverse reactions	Name fallback brand name: Torsemide generic name: TORSEMIDE
Torsemide	TORSEMIDE	Major Pharmaceuticals	09305350-e317-419c-96f5-aa8fbeb4044d	2026-03-26	Warnings, Adverse reactions	Name fallback brand name: Torsemide generic name: TORSEMIDE
Torsemide	TORSEMIDE	AvKARE	7fc14338-92e4-cf57-a3e8-ef64d8d1026c	2026-02-11	Warnings, Adverse reactions	Name fallback brand name: Torsemide generic name: TORSEMIDE
SOAANZ	TORSEMIDE	Sarfez Pharmaceuticals Inc	05eaa163-b6e9-438a-85f8-6a60e743d460	2026-01-09		Name fallback generic name: TORSEMIDE
Torsemide	TORSEMIDE	AvPAK	f1439b9c-c01c-a6d4-594b-d92b8e0af26e	2025-12-31	Warnings, Adverse reactions	Name fallback brand name: Torsemide generic name: TORSEMIDE
Torsemide	TORSEMIDE	Chartwell RX, LLC	a3d68763-95e0-4ad6-89c2-c4b1c0b43948	2025-12-10	Warnings, Adverse reactions	Name fallback brand name: Torsemide generic name: TORSEMIDE
Torsemide	TORSEMIDE	Redpharm Drug	44f2f06d-7bc4-5239-e063-6394a90aac5e	2025-12-02	Warnings, Adverse reactions	Name fallback brand name: Torsemide generic name: TORSEMIDE
Torsemide	TORSEMIDE	Bryant Ranch Prepack	0b3cfce4-61fc-42ba-9ea7-51f81ea014f7	2025-10-22	Warnings, Adverse reactions	Name fallback brand name: Torsemide generic name: TORSEMIDE
Torsemide	TORSEMIDE	Bryant Ranch Prepack	e707eda7-4bde-4944-ae19-1b4fa35b6a3c	2025-10-22	Warnings, Adverse reactions	Name fallback brand name: Torsemide generic name: TORSEMIDE
Torsemide	TORSEMIDE	Bryant Ranch Prepack	da8f2bf5-741c-45f6-b873-31a9fda2f880	2025-06-26	Warnings, Adverse reactions	Name fallback brand name: Torsemide generic name: TORSEMIDE
TORSEMIDE	TORSEMIDE	Direct_Rx	91d45625-5ba6-b50f-e053-2a95a90ac314	2025-01-17	Warnings, Adverse reactions	Name fallback brand name: TORSEMIDE generic name: TORSEMIDE
Torsemide	TORSEMIDE	Bryant Ranch Prepack	16dfba29-4c26-45e7-ac7d-b2ec2058e2bb	2024-11-04	Warnings, Adverse reactions	Name fallback brand name: Torsemide generic name: TORSEMIDE
Torsemide	TORSEMIDE	A-S Medication Solutions	e58a7d1c-6584-44c3-98ce-a3e9b64e9c82	2024-10-31	Warnings, Adverse reactions	Name fallback brand name: Torsemide generic name: TORSEMIDE
Torsemide	TORSEMIDE	American Health Packaging	aaabbaca-ba6f-42d5-980d-71135c7c80ea	2024-10-25	Warnings, Adverse reactions	Name fallback brand name: Torsemide generic name: TORSEMIDE
Torsemide	TORSEMIDE	Golden State Medical Supply, Inc.	2411e6f8-4fc3-f986-e063-6294a90a055a	2024-10-09	Warnings, Adverse reactions	Name fallback brand name: Torsemide generic name: TORSEMIDE
Torsemide	TORSEMIDE	A-S Medication Solutions	05c8a6ee-9517-453f-8dd6-7e5ca83c5a68	2024-10-01	Warnings, Adverse reactions	Name fallback brand name: Torsemide generic name: TORSEMIDE
Torsemide	TORSEMIDE	NCS HealthCare of KY, LLC dba Vangard Labs	99b537f3-1fbf-48b7-ac3e-0a43e6aab313	2024-09-30	Warnings, Adverse reactions	Name fallback brand name: Torsemide generic name: TORSEMIDE
Torsemide	TORSEMIDE	XLCare Pharmaceuticals Inc.	234ff9d7-a02e-417f-a1f9-94038783cc77	2024-09-10	Warnings, Adverse reactions	Name fallback brand name: Torsemide generic name: TORSEMIDE
Torsemide	TORSEMIDE	Bryant Ranch Prepack	13d851b6-3355-4541-93e8-73cdaf0f13d1	2024-07-16	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