Application 076943

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TORSEMIDE	TORSEMIDE	TABLET;ORAL	5MG	No	No
002	TORSEMIDE	TORSEMIDE	TABLET;ORAL	10MG	No	No
003	TORSEMIDE	TORSEMIDE	TABLET;ORAL	20MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A076943-001	TORSEMIDE	TORSEMIDE	5MG	TABLET / ORAL		2005-03-01
A076943-002	TORSEMIDE	TORSEMIDE	10MG	TABLET / ORAL		2005-03-01
A076943-003	TORSEMIDE	TORSEMIDE	20MG	TABLET / ORAL	AB	2005-03-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076943-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	A076943-001	TORSEMIDE	5MG	TABLET / ORAL		2005-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076943-002	TORSEMIDE	10MG	TABLET / ORAL		2005-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076943-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2005-03-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076943-001	TORSEMIDE	5MG	TABLET / ORAL		2005-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076943-002	TORSEMIDE	10MG	TABLET / ORAL		2005-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076943-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2005-03-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076943-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2005-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076943-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2005-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076943-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2005-03-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076943-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2005-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076943-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2005-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076943-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2005-03-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076943-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2005-03-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076943-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2005-03-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076943-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2005-03-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076943-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2005-03-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076943-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2005-03-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076943-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2005-03-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076943-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2005-03-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076943-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2005-03-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076943-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2005-03-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076943-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2005-03-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076943-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2005-03-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076943-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2005-03-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076943-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2005-03-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076943-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2005-03-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076943-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2005-03-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076943-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2005-03-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076943-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2005-03-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076943-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2005-03-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076943-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2005-03-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076943-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2005-03-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076943-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2005-03-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076943-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2005-03-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076943-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2005-03-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076943-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2005-03-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076943-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2005-03-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076943-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2005-03-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076943-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2005-03-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076943-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2005-03-01	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 117 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076943-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076943-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076943-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076943-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076943-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076943-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076943-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076943-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076943-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076943-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076943-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076943-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076943-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076943-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076943-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076943-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076943-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076943-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076943-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076943-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076943-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076943-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076943-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076943-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076943-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076943-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076943-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076943-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076943-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076943-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076943-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076943-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076943-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076943-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076943-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076943-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076943-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076943-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076943-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076943-002	AB	1	`5c6f7cd8ea54…`

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 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Torsemide	TORSEMIDE	REMEDYREPACK INC.	1c755d94-b846-4336-a968-aa1b92dc0ac0	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076943 application number: ANDA076943 ndc (product): 70518-2195
Torsemide	TORSEMIDE	Aphena Pharma Solutions - Tennessee, LLC	159e8c90-ebc6-0991-e063-6394a90aae19	2024-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076943 application number: ANDA076943
Torsemide	TORSEMIDE	Golden State Medical Supply, Inc.	a6055317-8826-df85-e053-2a95a90a5378	2023-12-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076943 application number: ANDA076943 ndc (product): 51407-362
Torsemide	TORSEMIDE	Hikma Pharmaceuticals USA Inc.	fde1d1be-0faa-440a-9039-bdb103288c76	2023-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076943 application number: ANDA076943 ndc (product): 0054-0077
Torsemide	TORSEMIDE	Aphena Pharma Solutions - Tennessee, LLC	b869bc45-1ebb-42fb-82c5-603f09835790	2017-10-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076943 application number: ANDA076943 ndc (product): 43353-315

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-0077	Torsemide	Torsemide	West-Ward Pharmaceuticals Corp.	ANDA	Current
43353-315	Torsemide	Torsemide	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
51407-362	Torsemide	Torsemide	Golden State Medical Supply	ANDA	Current
70518-2195	Torsemide	Torsemide	REMEDYREPACK INC.	ANDA	Current
70518-2195	Torsemide	Torsemide	REMEDYREPACK INC.	ANDA	Current
70518-2195	Torsemide	Torsemide	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22597	ORIG	2008-07-31