Application 076346

Type: ANDA
Sponsor: PLIVA PHARM IND

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 44.

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	RLD / RS	Approval date
A076346-001	TORSEMIDE	TORSEMIDE	5MG	TABLET / ORAL	AB		2003-05-30
A076346-002	TORSEMIDE	TORSEMIDE	10MG	TABLET / ORAL	AB		2003-05-30
A076346-003	TORSEMIDE	TORSEMIDE	20MG	TABLET / ORAL	AB	RS	2003-05-30
A076346-004	TORSEMIDE	TORSEMIDE	100MG	TABLET / ORAL	AB		2004-10-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076346-001	AB
A076346-002	AB
A076346-003	AB
A076346-004	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 3 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A076346-001	TORSEMIDE	5MG	TABLET / ORAL	AB		2003-05-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076346-002	TORSEMIDE	10MG	TABLET / ORAL	AB		2003-05-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076346-003	TORSEMIDE	20MG	TABLET / ORAL	AB		2003-05-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076346-004	TORSEMIDE	100MG	TABLET / ORAL	AB		2004-10-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076346-001	TORSEMIDE	5MG	TABLET / ORAL	AB		2003-05-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076346-002	TORSEMIDE	10MG	TABLET / ORAL	AB		2003-05-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076346-003	TORSEMIDE	20MG	TABLET / ORAL	AB	RS	2003-05-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076346-004	TORSEMIDE	100MG	TABLET / ORAL	AB		2004-10-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076346-001	TORSEMIDE	5MG	TABLET / ORAL	AB		2003-05-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076346-002	TORSEMIDE	10MG	TABLET / ORAL	AB		2003-05-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076346-003	TORSEMIDE	20MG	TABLET / ORAL	AB	RS	2003-05-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076346-004	TORSEMIDE	100MG	TABLET / ORAL	AB		2004-10-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076346-001	TORSEMIDE	5MG	TABLET / ORAL	AB		2003-05-30	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076346-002	TORSEMIDE	10MG	TABLET / ORAL	AB		2003-05-30	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076346-003	TORSEMIDE	20MG	TABLET / ORAL	AB	RS	2003-05-30	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076346-004	TORSEMIDE	100MG	TABLET / ORAL	AB		2004-10-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076346-001	TORSEMIDE	5MG	TABLET / ORAL	AB		2003-05-30	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A076346-002	TORSEMIDE	10MG	TABLET / ORAL	AB		2003-05-30	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A076346-003	TORSEMIDE	20MG	TABLET / ORAL	AB	RS	2003-05-30	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A076346-004	TORSEMIDE	100MG	TABLET / ORAL	AB		2004-10-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076346-001	TORSEMIDE	5MG	TABLET / ORAL	AB		2003-05-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A076346-002	TORSEMIDE	10MG	TABLET / ORAL	AB		2003-05-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A076346-003	TORSEMIDE	20MG	TABLET / ORAL	AB	RS	2003-05-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A076346-004	TORSEMIDE	100MG	TABLET / ORAL	AB		2004-10-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076346-001	TORSEMIDE	5MG	TABLET / ORAL	AB		2003-05-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076346-002	TORSEMIDE	10MG	TABLET / ORAL	AB		2003-05-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076346-003	TORSEMIDE	20MG	TABLET / ORAL	AB	RS	2003-05-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076346-004	TORSEMIDE	100MG	TABLET / ORAL	AB		2004-10-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076346-001	TORSEMIDE	5MG	TABLET / ORAL	AB		2003-05-30	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076346-002	TORSEMIDE	10MG	TABLET / ORAL	AB		2003-05-30	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076346-003	TORSEMIDE	20MG	TABLET / ORAL	AB		2003-05-30	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076346-004	TORSEMIDE	100MG	TABLET / ORAL	AB		2004-10-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076346-001	TORSEMIDE	5MG	TABLET / ORAL	AB		2003-05-30	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076346-002	TORSEMIDE	10MG	TABLET / ORAL	AB		2003-05-30	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076346-003	TORSEMIDE	20MG	TABLET / ORAL	AB		2003-05-30	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076346-004	TORSEMIDE	100MG	TABLET / ORAL	AB		2004-10-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076346-001	TORSEMIDE	5MG	TABLET / ORAL	AB		2003-05-30	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076346-002	TORSEMIDE	10MG	TABLET / ORAL	AB		2003-05-30	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076346-003	TORSEMIDE	20MG	TABLET / ORAL	AB		2003-05-30	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076346-004	TORSEMIDE	100MG	TABLET / ORAL	AB		2004-10-19	`ea99ee380514…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A076346-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A076346-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A076346-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A076346-004	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A076346-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076346-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076346-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076346-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076346-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076346-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076346-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076346-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076346-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076346-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076346-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076346-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076346-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076346-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076346-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076346-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076346-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076346-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076346-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076346-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076346-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076346-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076346-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076346-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076346-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076346-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076346-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076346-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076346-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076346-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076346-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076346-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076346-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076346-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076346-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076346-004	AB	1	`2680178bc6a6…`

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	AvKARE	7fc14338-92e4-cf57-a3e8-ef64d8d1026c	2026-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076346 application number: ANDA076346 ndc (product): 42291-816 ndc (product): 42291-819 ndc (product): 42291-817 ndc (product): 42291-818
Torsemide	TORSEMIDE	NCS HealthCare of KY, LLC dba Vangard Labs	99b537f3-1fbf-48b7-ac3e-0a43e6aab313	2024-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076346 application number: ANDA076346
Torsemide	TORSEMIDE	A-S Medication Solutions	3e9c6ee1-c49f-4f59-9391-8a9b57becb02	2023-05-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076346 application number: ANDA076346
Torsemide	TORSEMIDE	A-S Medication Solutions	3ed913ba-f0c0-4ba5-9440-73c4374f4226	2023-05-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076346 application number: ANDA076346
Torsemide	TORSEMIDE	Teva Pharmaceuticals USA, Inc.	8a95cbdb-0601-47a5-9b3a-0c3b0629ceb9	2017-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076346 application number: ANDA076346 ndc (product): 50111-916 ndc (product): 50111-917 ndc (product): 50111-915 ndc (product): 50111-918

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 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-5575	Torsemide	Torsemide	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
42291-816	Torsemide	Torsemide	AvKARE, Inc.	ANDA	Current
42291-816	Torsemide	Torsemide	AvKARE	ANDA	Current
42291-817	Torsemide	Torsemide	AvKARE, Inc.	ANDA	Current
42291-817	Torsemide	Torsemide	AvKARE	ANDA	Current
42291-818	Torsemide	Torsemide	AvKARE, Inc.	ANDA	Current
42291-818	Torsemide	Torsemide	AvKARE	ANDA	Current
42291-819	Torsemide	Torsemide	AvKARE, Inc.	ANDA	Current
42291-819	Torsemide	Torsemide	AvKARE	ANDA	Current
50111-915	Torsemide	Torsemide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50111-915	Torsemide	Torsemide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50111-915	Torsemide	Torsemide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50111-915	Torsemide	Torsemide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50111-916	Torsemide	Torsemide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50111-916	Torsemide	Torsemide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50111-916	Torsemide	Torsemide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50111-916	Torsemide	Torsemide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50111-917	Torsemide	Torsemide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50111-917	Torsemide	Torsemide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50111-917	Torsemide	Torsemide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50111-917	Torsemide	Torsemide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50111-918	Torsemide	Torsemide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50111-918	Torsemide	Torsemide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50111-918	Torsemide	Torsemide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50111-918	Torsemide	Torsemide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
55154-5766	Torsemide	Torsemide	Cardinal Health	ANDA	Current