Application 078249

Type: ANDA
Sponsor: AUROBINDO PHARMA

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
A078249-001	TORSEMIDE	TORSEMIDE	5MG	TABLET / ORAL	AB	2007-10-17
A078249-002	TORSEMIDE	TORSEMIDE	10MG	TABLET / ORAL	AB	2007-10-17
A078249-003	TORSEMIDE	TORSEMIDE	20MG	TABLET / ORAL	AB	2007-10-17
A078249-004	TORSEMIDE	TORSEMIDE	100MG	TABLET / ORAL	AB	2007-10-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078249-001	AB
A078249-002	AB
A078249-003	AB
A078249-004	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	A078249-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2007-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078249-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2007-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078249-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2007-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078249-004	TORSEMIDE	100MG	TABLET / ORAL	AB	2007-10-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078249-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2007-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078249-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2007-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078249-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2007-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078249-004	TORSEMIDE	100MG	TABLET / ORAL	AB	2007-10-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078249-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2007-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078249-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2007-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078249-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2007-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078249-004	TORSEMIDE	100MG	TABLET / ORAL	AB	2007-10-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078249-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2007-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078249-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2007-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078249-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2007-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078249-004	TORSEMIDE	100MG	TABLET / ORAL	AB	2007-10-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078249-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2007-10-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078249-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2007-10-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078249-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2007-10-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078249-004	TORSEMIDE	100MG	TABLET / ORAL	AB	2007-10-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078249-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2007-10-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078249-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2007-10-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078249-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2007-10-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078249-004	TORSEMIDE	100MG	TABLET / ORAL	AB	2007-10-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078249-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2007-10-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078249-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2007-10-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078249-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2007-10-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078249-004	TORSEMIDE	100MG	TABLET / ORAL	AB	2007-10-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078249-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2007-10-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078249-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2007-10-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078249-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2007-10-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078249-004	TORSEMIDE	100MG	TABLET / ORAL	AB	2007-10-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078249-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2007-10-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078249-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2007-10-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078249-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2007-10-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078249-004	TORSEMIDE	100MG	TABLET / ORAL	AB	2007-10-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078249-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2007-10-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078249-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2007-10-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078249-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2007-10-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078249-004	TORSEMIDE	100MG	TABLET / ORAL	AB	2007-10-17	`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	A078249-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078249-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078249-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078249-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078249-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078249-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078249-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078249-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078249-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078249-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078249-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078249-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078249-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078249-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078249-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078249-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078249-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078249-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078249-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078249-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078249-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078249-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078249-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078249-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078249-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078249-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078249-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078249-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078249-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078249-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078249-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078249-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078249-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078249-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078249-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078249-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078249-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078249-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078249-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078249-004	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Torsemide	TORSEMIDE	Redpharm Drug	44f2f06d-7bc4-5239-e063-6394a90aac5e	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078249 application number: ANDA078249
Torsemide	TORSEMIDE	Bryant Ranch Prepack	13d851b6-3355-4541-93e8-73cdaf0f13d1	2024-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078249 application number: ANDA078249 ndc (product): 71335-2143
Torsemide	TORSEMIDE	Aurobindo Pharma Limited	55e88727-864e-4313-860c-31a6ca45168f	2024-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078249 application number: ANDA078249 ndc (product): 65862-126 ndc (product): 65862-128 ndc (product): 65862-125 ndc (product): 65862-127
Torsemide	TORSEMIDE	Rising Pharma Holdings, Inc.	3c8f1c0b-8a44-4ca0-b2cf-3c591f8878fd	2024-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078249 application number: ANDA078249 ndc (product): 57237-140 ndc (product): 57237-139 ndc (product): 57237-138 ndc (product): 57237-141

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 29 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
57237-138	Torsemide	Torsemide	Rising Health, LLC	ANDA	Current
57237-138	Torsemide	Torsemide	Rising Health, LLC	ANDA	Current
57237-139	Torsemide	Torsemide	Rising Health, LLC	ANDA	Current
57237-139	Torsemide	Torsemide	Rising Health, LLC	ANDA	Current
57237-140	Torsemide	Torsemide	Rising Health, LLC	ANDA	Current
57237-140	Torsemide	Torsemide	Rising Health, LLC	ANDA	Current
57237-141	Torsemide	Torsemide	Rising Health, LLC	ANDA	Current
57237-141	Torsemide	Torsemide	Rising Health, LLC	ANDA	Current
65862-125	Torsemide	Torsemide	Aurobindo Pharma Limited	ANDA	Current
65862-125	Torsemide	Torsemide	Aurobindo Pharma Limited	ANDA	Current
65862-125	Torsemide	Torsemide	Aurobindo Pharma Limited	ANDA	Current
65862-125	Torsemide	Torsemide	Aurobindo Pharma Limited	ANDA	Current
65862-126	Torsemide	Torsemide	Aurobindo Pharma Limited	ANDA	Current
65862-126	Torsemide	Torsemide	Aurobindo Pharma Limited	ANDA	Current
65862-126	Torsemide	Torsemide	Aurobindo Pharma Limited	ANDA	Current
65862-126	Torsemide	Torsemide	Aurobindo Pharma Limited	ANDA	Current
65862-127	Torsemide	Torsemide	Aurobindo Pharma Limited	ANDA	Current
65862-127	Torsemide	Torsemide	Aurobindo Pharma Limited	ANDA	Current
65862-127	Torsemide	Torsemide	Aurobindo Pharma Limited	ANDA	Current
65862-127	Torsemide	Torsemide	Aurobindo Pharma Limited	ANDA	Current
65862-128	Torsemide	Torsemide	Aurobindo Pharma Limited	ANDA	Current
65862-128	Torsemide	Torsemide	Aurobindo Pharma Limited	ANDA	Current
65862-128	Torsemide	Torsemide	Aurobindo Pharma Limited	ANDA	Current
65862-128	Torsemide	Torsemide	Aurobindo Pharma Limited	ANDA	Current
71335-0297	Torsemide	Torsemide	Bryant Ranch Prepack	ANDA	Current
71335-0297	Torsemide	Torsemide	Bryant Ranch Prepack	ANDA	Current
71335-0297	Torsemide	Torsemide	Bryant Ranch Prepack	ANDA	Current
71335-2143	Torsemide	Torsemide	Bryant Ranch Prepack	ANDA	Current
72189-030	TORSEMIDE	TORSEMIDE	Direct_Rx	ANDA	Current