Application 091590

Type: ANDA
Sponsor: MYLAN

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
A091590-001	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06
A091590-002	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06
A091590-003	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	A091590-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091590-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091590-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091590-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091590-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091590-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091590-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091590-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091590-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091590-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091590-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091590-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091590-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091590-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091590-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091590-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091590-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091590-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091590-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091590-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091590-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091590-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091590-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091590-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091590-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091590-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091590-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091590-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091590-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091590-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091590-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091590-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091590-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091590-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091590-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091590-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091590-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091590-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091590-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091590-001	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
2019-12-13 00:20 UTC	2019-12	A091590-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091590-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091590-003	AB	1	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	A091590-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091590-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091590-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091590-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091590-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091590-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091590-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091590-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091590-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091590-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091590-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091590-003	AB	1	`ea99ee380514…`

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 2 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	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
Losartan Potassium	LOSARTAN POTASSIUM	Cardinal Health 107, LLC	b83d896a-c7e9-4508-814c-425b88a87b16	2026-06-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Bryant Ranch Prepack	0f3a6984-e601-4a74-9910-49ee5e352d6b	2026-06-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Coupler LLC	53456224-db79-e7c1-e063-6394a90a90d5	2026-06-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Preferred Pharmaceuticals Inc.	c4b81f90-bcd0-45d0-99ce-35ca998d473a	2026-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losortan Potassium	LOSARTAN POTASSIUM	Preferred Pharmaceuticals Inc.	25651749-8950-43ff-bcbd-3bb85f57a360	2026-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Preferred Pharmaceuticals, Inc.	fe1df76d-4925-444d-8e30-9dd07f205fb7	2026-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	PD-Rx Pharmaceuticals, Inc.	f9a92771-5c73-4f17-ac38-29fabfd4a919	2026-05-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	PD-Rx Pharmaceuticals, Inc.	5f7612dc-dccf-49e2-b541-3dab9dc1f97a	2026-05-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	PD-Rx Pharmaceuticals, Inc.	abb56236-f2fe-45b5-93ac-35fd661f8992	2026-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losortan Potassium	LOSARTAN POTASSIUM	Bryant Ranch Prepack	1b285c10-f468-4d87-b36d-79047f686c58	2026-05-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	A-S Medication Solutions	23117ad8-39ad-44f2-b7d2-2dbc8edc9734	2026-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	A-S Medication Solutions	d7b61f05-871d-4ffd-ab9b-9a3e60fd34c4	2026-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan potassium	LOSARTAN POTASSIUM	Preferred Pharmaceuticals Inc.	05818573-0b40-4731-a9d1-152c708905bf	2026-03-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan potassium generic name: LOSARTAN POTASSIUM
LOSARTAN POTASSIUM 25 mg	LOSARTAN POTASSIUM	PD-Rx Pharmaceuticals, Inc.	4d60e755-40a6-4187-b09e-e55c735945aa	2026-02-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	NuCare Pharmaceuticals,Inc.	ba76eb91-bea6-4e37-e053-2a95a90a065a	2026-02-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
LOSARTAN POTASSIUM 25 mg	LOSARTAN POTASSIUM	PD-Rx Pharmaceuticals, Inc.	372ba4ad-26ca-4675-8475-4b664fbecba9	2026-02-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	A-S Medication Solutions	3ee3240f-78a1-4fd2-a779-c22693711721	2026-02-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	A-S Medication Solutions	f29cc61a-afba-4ecb-8043-5f103872f1ae	2026-02-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	A-S Medication Solutions	2c810cde-fa40-4772-806e-c31809e6bbfb	2026-02-11	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.