Application 091129

Type: ANDA
Sponsor: WATSON LABS

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 43.

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
A091129-001	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06
A091129-002	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06
A091129-003	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
A091129-001	AB
A091129-002	AB
A091129-003	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 · 129 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
2026-09-14 22:38:34	2026-08	A091129-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091129-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091129-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091129-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091129-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091129-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091129-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091129-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091129-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091129-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091129-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091129-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091129-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091129-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091129-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091129-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091129-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091129-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091129-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091129-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091129-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091129-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091129-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091129-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091129-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091129-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091129-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091129-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091129-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091129-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091129-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091129-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091129-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091129-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091129-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091129-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091129-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091129-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091129-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091129-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A091129-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091129-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091129-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091129-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091129-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091129-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091129-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091129-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091129-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091129-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091129-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091129-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091129-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091129-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091129-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091129-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091129-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091129-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091129-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091129-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091129-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091129-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091129-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091129-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091129-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091129-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091129-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091129-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091129-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091129-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091129-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091129-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091129-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091129-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091129-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091129-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091129-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091129-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091129-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091129-001	AB	1	`301d65b070ca…`

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 5 of 7 · 137 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Losartan Potassium	LOSARTAN POTASSIUM	Solco Healthcare US, LLC	fa0cf2c2-6238-4edd-94e2-b670b98a0da4	2025-08-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Preferred Pharmaceuticals Inc.	94eb89aa-296f-4e8f-a077-30a1be01ad52	2025-08-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Preferred Pharmaceuticals Inc.	68ed9727-987e-4bb6-98b4-b98150bb6404	2025-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan potassium	LOSARTAN POTASSIUM	Macleods Pharmaceuticals Limited	85d69d02-c5ef-467e-94aa-903100218795	2025-07-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN	Granules India Ltd	f9953f51-f30a-952d-e053-6394a90abf5f	2025-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium
Losartan Potassium	LOSARTAN POTASSIUM	Alembic Pharmaceuticals Inc.	1dadbe02-289c-4312-9e65-40f3314dcc31	2025-07-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Bryant Ranch Prepack	35856cd6-3fc7-2c03-e063-6294a90a2f69	2025-05-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Bryant Ranch Prepack	3585b1d3-ccb7-747e-e063-6294a90a4b77	2025-05-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Bryant Ranch Prepack	3585fdcc-d22a-b0a6-e063-6294a90a9b0c	2025-05-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	NuCare Pharmaceuticals.Inc.	351d3c5c-05c6-921a-e063-6394a90abef9	2025-05-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	A-S Medication Solutions	27e783ce-3353-448a-b0a3-c954dfd2e4c7	2025-04-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	NuCare Pharmaceuticals,Inc.	adc984d5-91d6-ef17-e053-2a95a90a7571	2025-02-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan potassium	LOSARTAN POTASSIUM	Coupler LLC	2d5524d5-c76b-44af-e063-6294a90a2ef1	2025-02-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan potassium generic name: LOSARTAN POTASSIUM
Losartan potassium	LOSARTAN POTASSIUM	Coupler LLC	2d1b1648-8b24-cf4f-e063-6294a90afdd8	2025-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan potassium generic name: LOSARTAN POTASSIUM
Losartan potassium Tablets, 100 mg	LOSARTAN POTASSIUM	Coupler LLC	2d1b03bb-2355-baac-e063-6294a90a9b40	2025-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	DirectRx	d358499d-5ebb-75b2-e053-2a95a90a4223	2025-01-20	Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Direct_Rx	e9aa536e-0747-45bf-e053-2995a90ae7d6	2025-01-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	DIRECT RX	a5b5da65-a4d5-1bd5-e053-2a95a90a6a60	2025-01-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LOSARTAN POTASSIUM generic name: LOSARTAN POTASSIUM
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	DIRECT RX	a58c56b2-e05c-6697-e053-2a95a90ad466	2025-01-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LOSARTAN POTASSIUM generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	NuCare Pharmaceuticals,Inc.	de5c0c87-e90b-fc14-e053-2a95a90af0c5	2024-12-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60429-316	Losartan Potassium	Losartan Potassium	Golden State Medical Supply, Inc.	ANDA	Current
60429-316	Losartan Potassium	Losartan Potassium	Golden State Medical Supply, Inc.	ANDA	Current
60429-317	Losartan Potassium	Losartan Potassium	Golden State Medical Supply, Inc.	ANDA	Current
60429-317	Losartan Potassium	Losartan Potassium	Golden State Medical Supply, Inc.	ANDA	Current
60429-318	Losartan Potassium	Losartan Potassium	Golden State Medical Supply, Inc.	ANDA	Current
60429-318	Losartan Potassium	Losartan Potassium	Golden State Medical Supply, Inc.	ANDA	Current