Application 078232

Type: ANDA
Sponsor: LUPIN LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	TABLET;ORAL	25MG	No	No
002	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	TABLET;ORAL	50MG	No	No
003	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	TABLET;ORAL	100MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A078232-001	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06
A078232-002	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06
A078232-003	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A078232-001	AB
A078232-002	AB
A078232-003	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 · 126 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
2026-08-18 06:07:40	2026-07	A078232-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078232-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078232-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078232-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078232-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078232-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078232-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078232-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078232-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078232-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078232-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078232-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078232-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078232-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078232-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078232-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078232-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078232-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078232-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078232-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078232-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078232-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078232-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078232-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078232-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078232-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078232-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078232-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078232-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078232-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078232-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078232-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078232-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078232-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078232-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078232-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078232-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078232-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078232-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078232-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A078232-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078232-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078232-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078232-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078232-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078232-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078232-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078232-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078232-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078232-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078232-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078232-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078232-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078232-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078232-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078232-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078232-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078232-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078232-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078232-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078232-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078232-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078232-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078232-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078232-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078232-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078232-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078232-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078232-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078232-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078232-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078232-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078232-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078232-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078232-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078232-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078232-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078232-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078232-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078232-001	AB	1	`1e350fbaab3a…`

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
Losartan Potassium	LOSARTAN POTASSIUM	REMEDYREPACK INC.	c43e9dc6-2c8a-47d7-b40d-eb55dfe11a51	2026-08-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078232 application number: ANDA078232 ndc (product): 70518-3282
Losartan Potassium	LOSARTAN POTASSIUM	Lupin Pharmaceuticals, Inc.	e5886220-43b7-46e1-9034-5242ba245bd1	2026-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078232 application number: ANDA078232 ndc (product): 68180-376 ndc (product): 68180-378 ndc (product): 68180-377 ndc (product): 68180-210
Losartan Potassium	LOSARTAN POTASSIUM	A-S Medication Solutions	7a945396-dd71-4b16-bfab-947982407f36	2024-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078232 application number: ANDA078232 ndc (product): 50090-5626
Losartan Potassium	LOSARTAN POTASSIUM	A-S Medication Solutions	679be0b9-bb60-4970-ad50-0041a6d67bf8	2023-03-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078232 application number: ANDA078232 ndc (product): 50090-3403
Losartan Potassium	LOSARTAN POTASSIUM	A-S Medication Solutions	0e0a06f3-b8bd-4178-a519-ed80362e33c2	2023-03-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078232 application number: ANDA078232 ndc (product): 50090-5480

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-3231	Losartan Potassium	Losartan Potassium	A-S Medication Solutions	ANDA	Current
50090-3403	Losartan Potassium	Losartan Potassium	A-S Medication Solutions	ANDA	Current
50090-5480	Losartan Potassium	Losartan Potassium	A-S Medication Solutions	ANDA	Current
50090-5480	Losartan Potassium	Losartan Potassium	A-S Medication Solutions	ANDA	Current
50090-5481	Losartan Potassium	Losartan Potassium	A-S Medication Solutions	ANDA	Current
50090-5626	Losartan Potassium	Losartan Potassium	A-S Medication Solutions	ANDA	Current
68180-210	Losartan Potassium	Losartan Potassium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-210	Losartan Potassium	Losartan Potassium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-376	Losartan Potassium	Losartan Potassium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-376	Losartan Potassium	Losartan Potassium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-376	Losartan Potassium	Losartan Potassium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-376	Losartan Potassium	Losartan Potassium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-376	Losartan Potassium	Losartan Potassium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-377	Losartan Potassium	Losartan Potassium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-377	Losartan Potassium	Losartan Potassium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-377	Losartan Potassium	Losartan Potassium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-377	Losartan Potassium	Losartan Potassium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-377	Losartan Potassium	Losartan Potassium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-378	Losartan Potassium	Losartan Potassium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-378	Losartan Potassium	Losartan Potassium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-378	Losartan Potassium	Losartan Potassium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-378	Losartan Potassium	Losartan Potassium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-378	Losartan Potassium	Losartan Potassium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68645-524	Losartan Potassium	Losartan Potassium	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-525	Losartan Potassium	Losartan Potassium	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-526	Losartan Potassium	Losartan Potassium	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68788-7914	Losartan Potassium	Losartan Potassium	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7914	Losartan Potassium	Losartan Potassium	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-3282	Losartan Potassium	Losartan Potassium	REMEDYREPACK INC.	ANDA	Current
70518-3282	Losartan Potassium	Losartan Potassium	REMEDYREPACK INC.	ANDA	Current