Application 218551

Type: ANDA
Sponsor: APOTEX

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	Approval date
A218551-001	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2024-06-04
A218551-002	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2024-06-04
A218551-003	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2024-06-04

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 2 · 45 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	A218551-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL		2024-06-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218551-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL		2024-06-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218551-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL		2024-06-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218551-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL		2024-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218551-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL		2024-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218551-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL		2024-06-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218551-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL		2024-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218551-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL		2024-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218551-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL		2024-06-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218551-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL		2024-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218551-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL		2024-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218551-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL		2024-06-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218551-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL		2024-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218551-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL		2024-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218551-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL		2024-06-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218551-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL		2024-06-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218551-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL		2024-06-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218551-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL		2024-06-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218551-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2024-06-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218551-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2024-06-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218551-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2024-06-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218551-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2024-06-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218551-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2024-06-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218551-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2024-06-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218551-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2024-06-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218551-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2024-06-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218551-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2024-06-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218551-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2024-06-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218551-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2024-06-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218551-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2024-06-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218551-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2024-06-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A218551-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2024-06-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A218551-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2024-06-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A218551-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2024-06-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A218551-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2024-06-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A218551-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2024-06-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A218551-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2024-06-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A218551-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2024-06-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A218551-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2024-06-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A218551-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2024-06-04	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218551-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218551-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218551-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218551-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218551-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218551-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218551-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218551-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218551-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218551-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218551-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218551-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218551-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A218551-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A218551-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A218551-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A218551-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A218551-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A218551-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A218551-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A218551-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A218551-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A218551-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A218551-003	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 8 · 141 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Losartan Potassium	LOSARTAN POTASSIUM	REMEDYREPACK INC.	e136356b-e4d2-4e00-a409-35825c5637c9	2026-08-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	REMEDYREPACK INC.	c43e9dc6-2c8a-47d7-b40d-eb55dfe11a51	2026-08-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Redpharm Drug	5833c02c-9957-a069-e063-6294a90ad3e4	2026-08-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Major Pharmaceuticals	c15387df-87a4-4784-acb5-7dd550498f8f	2026-07-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	REMEDYREPACK INC.	df4f55f0-fb11-4f6f-a7ed-127b50f955fc	2026-07-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Zydus Pharmaceuticals USA Inc.	3233c707-70b6-4c29-8210-913eeb2a38ed	2026-07-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	REMEDYREPACK INC.	f7cf8a7d-90f1-46a3-abff-1eb316aa7d72	2026-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN	Preferred Pharmaceuticals Inc.	9501dfaa-c8cf-46d6-8bec-936c4fd8fe03	2026-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium
Losartan Potassium	LOSARTAN POTASSIUM	REMEDYREPACK INC.	6f39f7f9-edac-45ca-9ee2-c2ecad0915ab	2026-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	PD-Rx Pharmaceuticals, Inc.	1843ee4b-1afc-4992-993a-4b0e03e785fc	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	PD-Rx Pharmaceuticals, Inc.	9b3ddaa2-a835-736a-e053-2995a90aff08	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	REMEDYREPACK INC.	25c93638-7016-47d2-a57c-e4a5245ca41b	2026-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Unit Dose Solutions, Inc.	5529733c-1e3b-e590-e063-6294a90a765c	2026-06-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Unit Dose Solutions, Inc.	552a2f78-6318-310f-e063-6394a90abb15	2026-06-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	REMEDYREPACK INC.	41069514-0491-41fe-b7fe-a52d42d33848	2026-06-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	American Health Packaging	e7f6b25b-ec4c-4c3a-a541-617d2d9ab393	2026-06-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	REMEDYREPACK INC.	45c01cc9-c7d1-4bb6-a105-354fc936ec63	2026-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Coupler LLC	53e82c07-fe4c-78db-e063-6394a90a8087	2026-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan potassium	LOSARTAN POTASSIUM	Preferred Pharmaceuticals Inc.	628d0317-b844-42a0-9c27-48e1e23a38f5	2026-06-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	St. Mary's Medical Park Pharmacy	aaf943ff-d6af-8ce2-e053-2995a90a7b76	2026-06-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM