Application 079234

Type: ANDA
Sponsor: HETERO LABS LTD III

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
004	TORSEMIDE	TORSEMIDE	TABLET;ORAL	100MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A079234-001	TORSEMIDE	TORSEMIDE	5MG	TABLET / ORAL	AB	2009-01-27
A079234-002	TORSEMIDE	TORSEMIDE	10MG	TABLET / ORAL	AB	2009-01-27
A079234-003	TORSEMIDE	TORSEMIDE	20MG	TABLET / ORAL	AB	2009-01-27
A079234-004	TORSEMIDE	TORSEMIDE	100MG	TABLET / ORAL	AB	2009-01-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A079234-001	AB
A079234-002	AB
A079234-003	AB
A079234-004	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 5 · 164 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	A079234-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2009-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079234-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2009-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079234-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2009-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079234-004	TORSEMIDE	100MG	TABLET / ORAL	AB	2009-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079234-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2009-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079234-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2009-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079234-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2009-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079234-004	TORSEMIDE	100MG	TABLET / ORAL	AB	2009-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079234-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2009-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079234-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2009-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079234-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2009-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079234-004	TORSEMIDE	100MG	TABLET / ORAL	AB	2009-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079234-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2009-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079234-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2009-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079234-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2009-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079234-004	TORSEMIDE	100MG	TABLET / ORAL	AB	2009-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079234-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2009-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079234-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2009-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079234-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2009-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079234-004	TORSEMIDE	100MG	TABLET / ORAL	AB	2009-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079234-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2009-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079234-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2009-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079234-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2009-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079234-004	TORSEMIDE	100MG	TABLET / ORAL	AB	2009-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079234-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2009-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079234-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2009-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079234-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2009-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079234-004	TORSEMIDE	100MG	TABLET / ORAL	AB	2009-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079234-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2009-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079234-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2009-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079234-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2009-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079234-004	TORSEMIDE	100MG	TABLET / ORAL	AB	2009-01-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079234-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2009-01-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079234-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2009-01-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079234-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2009-01-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079234-004	TORSEMIDE	100MG	TABLET / ORAL	AB	2009-01-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079234-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2009-01-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079234-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2009-01-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079234-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2009-01-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079234-004	TORSEMIDE	100MG	TABLET / ORAL	AB	2009-01-27	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A079234-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079234-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079234-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079234-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079234-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079234-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079234-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079234-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079234-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079234-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079234-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079234-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079234-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079234-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079234-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079234-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079234-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079234-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079234-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079234-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079234-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079234-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079234-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079234-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079234-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079234-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079234-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079234-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079234-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079234-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079234-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079234-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079234-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079234-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079234-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079234-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079234-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079234-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079234-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079234-004	AB	1	`d06236e962d9…`

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Torsemide	TORSEMIDE	Major Pharmaceuticals	09305350-e317-419c-96f5-aa8fbeb4044d	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079234 application number: ANDA079234
Torsemide	TORSEMIDE	AvPAK	f1439b9c-c01c-a6d4-594b-d92b8e0af26e	2025-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079234 application number: ANDA079234 ndc (product): 50268-757 ndc (product): 50268-754 ndc (product): 50268-756 ndc (product): 50268-755
TORSEMIDE	TORSEMIDE	Direct_Rx	91d45625-5ba6-b50f-e053-2a95a90ac314	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079234 application number: ANDA079234 ndc (product): 72189-102
Torsemide	TORSEMIDE	A-S Medication Solutions	e58a7d1c-6584-44c3-98ce-a3e9b64e9c82	2024-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079234 application number: ANDA079234
Torsemide	TORSEMIDE	American Health Packaging	aaabbaca-ba6f-42d5-980d-71135c7c80ea	2024-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079234 application number: ANDA079234 ndc (product): 68084-539
Torsemide	TORSEMIDE	A-S Medication Solutions	05c8a6ee-9517-453f-8dd6-7e5ca83c5a68	2024-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079234 application number: ANDA079234
Torsemide	TORSEMIDE	XLCare Pharmaceuticals Inc.	234ff9d7-a02e-417f-a1f9-94038783cc77	2024-09-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079234 application number: ANDA079234
Torsemide	TORSEMIDE	Bryant Ranch Prepack	f24151c8-02cd-4b07-a7fd-796903210aba	2023-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079234 application number: ANDA079234 ndc (product): 63629-1346
Torsemide	TORSEMIDE	NCS HealthCare of KY, LLC dba Vangard Labs	201e892d-d963-4c6a-b35b-c5780b01f659	2022-12-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079234 application number: ANDA079234 ndc (product): 0615-7997
Torsemide	TORSEMIDE	Camber Pharmaceuticals, Inc.	0d4a4ef9-0944-452c-b014-bd822bfb9dd9	2017-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079234 application number: ANDA079234 ndc (product): 31722-529 ndc (product): 31722-531 ndc (product): 31722-532 ndc (product): 31722-530

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-7997	Torsemide	Torsemide	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7997	Torsemide	Torsemide	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
31722-529	Torsemide	Torsemide	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-530	Torsemide	Torsemide	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-531	Torsemide	Torsemide	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-532	Torsemide	Torsemide	Camber Pharmaceuticals, Inc.	ANDA	Current
50268-754	Torsemide	Torsemide	AvPAK	ANDA	Current
50268-754	Torsemide	Torsemide	AvPAK	ANDA	Current
50268-754	Torsemide	Torsemide	AvPAK	ANDA	Current
50268-755	Torsemide	Torsemide	AvPAK	ANDA	Current
50268-755	Torsemide	Torsemide	AvPAK	ANDA	Current
50268-755	Torsemide	Torsemide	AvPAK	ANDA	Current
50268-756	Torsemide	Torsemide	AvPAK	ANDA	Current
50268-756	Torsemide	Torsemide	AvPAK	ANDA	Current
50268-756	Torsemide	Torsemide	AvPAK	ANDA	Current
50268-757	Torsemide	Torsemide	AvPAK	ANDA	Current
50268-757	Torsemide	Torsemide	AvPAK	ANDA	Current
50268-757	Torsemide	Torsemide	AvPAK	ANDA	Current
63629-1346	Torsemide	Torsemide	Bryant Ranch Prepack	ANDA	Current
63629-1346	Torsemide	Torsemide	Bryant Ranch Prepack	ANDA	Current
63629-4475	Torsemide	Torsemide	Bryant Ranch Prepack	ANDA	Current
68084-539	Torsemide	Torsemide	American Health Packaging	ANDA	Current
68084-539	Torsemide	Torsemide	American Health Packaging	ANDA	Current
68084-539	Torsemide	Torsemide	American Health Packaging	ANDA	Current
68151-2946	Torsemide	Torsemide	Carilion Materials Management	ANDA	Current
68151-2948	Torsemide	Torsemide	Carilion Materials Management	ANDA	Current
68151-2949	Torsemide	Torsemide	Carilion Materials Management	ANDA	Current
70518-2744	Torsemide	Torsemide	REMEDYREPACK INC.	ANDA	Current
70518-2744	Torsemide	Torsemide	REMEDYREPACK INC.	ANDA	Current
70518-2744	Torsemide	Torsemide	REMEDYREPACK INC.	ANDA	Current
70518-2744	Torsemide	Torsemide	REMEDYREPACK INC.	ANDA	Current
72189-102	TORSEMIDE	TORSEMIDE	Direct_Rx	ANDA	Current
72189-102	TORSEMIDE	TORSEMIDE	Direct_Rx	ANDA	Current