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 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	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 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077459-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077459-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077459-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077459-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077459-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077459-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077459-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077459-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077459-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077459-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077459-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077459-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077459-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077459-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077459-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077459-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077459-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077459-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077459-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077459-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077459-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077459-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077459-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077459-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077459-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077459-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077459-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077459-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077459-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077459-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077459-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077459-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077459-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077459-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077459-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077459-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077459-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077459-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077459-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077459-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`301d65b070ca…`

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 7 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	XLCare Pharmaceuticals, Inc.	20421665-0401-4f6e-9e1d-232c654efb0f	2023-01-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LOSARTAN POTASSIUM generic name: LOSARTAN POTASSIUM
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	Aphena Pharma Solutions - Tennessee, LLC	8015c22c-d944-4a49-8721-70d0c1b98526	2022-10-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LOSARTAN POTASSIUM generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Proficient Rx LP	5b1f6677-9473-467f-9fb6-efadbd8828e8	2022-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Proficient Rx LP	c0319153-3e35-4a84-aa63-935b1e0047d8	2022-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Proficient Rx LP	1b3c03e8-da8e-4c25-a493-118e760a003b	2022-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Proficient Rx LP	aeb4ce44-ab34-4f0e-a674-de42d404d104	2022-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
LOSARTAN POTASSIUM 25 mg	LOSARTAN POTASSIUM	Proficient Rx LP	e8075254-cdfd-44f3-a9c2-1ed913f846ea	2022-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOSARTAN POTASSIUM
LOSARTAN POTASSIUM 50 mg	LOSARTAN POTASSIUM	Proficient Rx LP	f260f7c5-a55b-4294-ae02-2586929e24c9	2021-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Proficient Rx LP	435c5544-491b-476a-b950-712b2c18e334	2020-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	Aphena Pharma Solutions - Tennessee, LLC	2f738295-53d6-4d4f-8864-9faf893dbdf2	2020-10-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LOSARTAN POTASSIUM generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Aphena Pharma Solutions - Tennessee, LLC	be2432ba-2118-418a-addf-56db9b6c39d2	2020-10-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losortan Potassium	LOSARTAN POTASSIUM	Proficient Rx LP	364fe10e-11ca-4ee6-9f67-c85dec09aca5	2019-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Proficient Rx LP	44050993-c20e-45d4-baeb-f77d91296168	2019-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Aphena Pharma Solutions - Tennessee, LLC	35e3472a-457f-4f95-a78d-dbff2595171d	2019-01-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Aphena Pharma Solutions - Tennessee, LLC	1f55aaa2-5848-47e0-bba0-6a70b2fa05dd	2018-12-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Aphena Pharma Solutions - Tennessee, LLC	3bcbcb6c-ee8d-44b1-9c78-92712291e891	2018-10-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Aphena Pharma Solutions - Tennessee, LLC	8081b9f8-0b52-46dd-93f2-6bc608b75339	2018-07-09	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