Application 077459

Type: ANDA
Sponsor: HIKMA

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 44.

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
A077459-001	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06
A077459-002	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06
A077459-003	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06

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 4 · 132 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
2020-11-12 02:37 UTC	2020-11	A077459-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL		2010-10-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077459-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077459-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077459-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077459-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077459-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077459-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077459-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077459-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077459-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077459-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL		2010-10-06	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077459-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL		2010-10-06	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077459-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL		2010-10-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077459-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL		2010-10-06	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A077459-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL		2010-10-06	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A077459-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL		2010-10-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077459-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL		2010-10-06	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A077459-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL		2010-10-06	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A077459-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL		2010-10-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077459-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL		2010-10-06	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077459-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL		2010-10-06	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077459-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL		2010-10-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077459-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL		2010-10-06	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077459-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL		2010-10-06	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077459-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL		2010-10-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077459-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL		2010-10-06	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077459-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL		2010-10-06	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077459-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL		2010-10-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077459-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL		2010-10-06	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077459-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL		2010-10-06	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077459-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL		2010-10-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077459-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL		2010-10-06	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A077459-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL		2010-10-06	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A077459-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL		2010-10-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077459-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL		2010-10-06	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A077459-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL		2010-10-06	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A077459-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL		2010-10-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077459-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL		2010-10-06	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077459-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL		2010-10-06	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077459-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL		2010-10-06	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077459-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077459-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077459-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077459-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077459-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077459-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077459-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077459-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077459-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077459-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077459-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077459-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077459-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077459-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077459-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077459-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077459-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077459-003	AB	1	`782e0a99824c…`
2019-12-14 00:12 UTC	2019-12	A077459-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077459-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077459-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077459-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077459-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077459-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077459-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077459-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077459-003	AB	1	`ea99ee380514…`
2022-10-28 04:53 UTC	2022-10	A077459-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A077459-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077459-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A077459-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077459-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077459-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077459-003	AB	1	`cb3db0bc1861…`

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 7 · 134 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Losartan potassium	LOSARTAN POTASSIUM	REMEDYREPACK INC.	a397502e-abe7-49cf-97c7-d53a616947eb	2026-09-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Cardinal Health 107, LLC	021cd76a-b093-4704-8410-5e7d01e20a54	2026-08-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
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	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

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 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-0123	Losartan Potassium	Losartan Potassium	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0123	Losartan Potassium	Losartan Potassium	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0123	Losartan Potassium	Losartan Potassium	West-Ward Pharmaceuticals	ANDA	Current
0054-0124	Losartan Potassium	Losartan Potassium	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0124	Losartan Potassium	Losartan Potassium	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0124	Losartan Potassium	Losartan Potassium	West-Ward Pharmaceuticals	ANDA	Current
0054-0125	Losartan Potassium	Losartan Potassium	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0125	Losartan Potassium	Losartan Potassium	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0125	Losartan Potassium	Losartan Potassium	West-Ward Pharmaceuticals	ANDA	Current
68071-4380	Losartan Potassium	Losartan Potassium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4380	Losartan Potassium	Losartan Potassium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4380	Losartan Potassium	Losartan Potassium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4597	Losartan Potassium	Losartan Potassium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5095	Losartan Potassium	Losartan Potassium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5095	Losartan Potassium	Losartan Potassium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5159	Losartan Potassium	Losartan Potassium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5159	Losartan Potassium	Losartan Potassium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5183	Losartan Potassium	Losartan Potassium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5183	Losartan Potassium	Losartan Potassium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5184	Losartan Potassium	Losartan Potassium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5184	Losartan Potassium	Losartan Potassium	NuCare Pharmaceuticals,Inc.	ANDA	Current
71335-1328	Losartan Potassium	Losartan Potassium	Bryant Ranch Prepack	ANDA	Current
71335-1328	Losartan Potassium	Losartan Potassium	Bryant Ranch Prepack	ANDA	Current
71335-1328	Losartan Potassium	Losartan Potassium	Bryant Ranch Prepack	ANDA	Current
71335-1345	Losartan Potassium	Losartan Potassium	Bryant Ranch Prepack	ANDA	Current
71335-1345	Losartan Potassium	Losartan Potassium	Bryant Ranch Prepack	ANDA	Current
71335-1439	Losartan Potassium	Losartan Potassium	Bryant Ranch Prepack	ANDA	Current
71335-1439	Losartan Potassium	Losartan Potassium	Bryant Ranch Prepack	ANDA	Current
72189-317	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	DirectRx	ANDA	Current
72189-317	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	DirectRx	ANDA	Current