Application 091652

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM	TABLET;ORAL	12.5MG;50MG	No	No
002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM	TABLET;ORAL	12.5MG;100MG	No	No
003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM	TABLET;ORAL	25MG;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
A091652-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM	12.5MG;50MG	TABLET / ORAL	2010-10-06
A091652-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM	12.5MG;100MG	TABLET / ORAL	2010-04-06
A091652-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM	25MG;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	A091652-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	2010-10-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091652-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	2010-04-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091652-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	2010-10-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091652-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	2010-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091652-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	2010-04-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091652-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	2010-10-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091652-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	2010-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091652-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	2010-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091652-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	2010-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091652-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	2010-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091652-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	2010-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091652-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	2010-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091652-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	2010-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091652-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	2010-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091652-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	2010-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091652-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	2010-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091652-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	2010-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091652-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	2010-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091652-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	2010-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091652-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	2010-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091652-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	2010-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091652-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	2010-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091652-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	2010-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091652-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	2010-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091652-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	2010-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091652-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	2010-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091652-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	2010-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091652-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	2010-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091652-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	2010-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091652-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	2010-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091652-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	2010-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091652-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	2010-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091652-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	2010-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091652-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	2010-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091652-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	2010-04-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091652-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	2010-10-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091652-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	2010-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091652-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	2010-04-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091652-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	2010-10-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091652-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	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	A091652-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091652-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091652-003	AB	1	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	A091652-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091652-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091652-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091652-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091652-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091652-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091652-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091652-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091652-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091652-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091652-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091652-003	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 3 of 4 · 75 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Granules Pharmaceuticals Inc.	b4168479-09ec-402c-89cc-456bc8485017	2025-07-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Losartan potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Macleods Pharmaceuticals Limited	a04b5622-2c49-4d61-92b1-5dc523af7a24	2025-07-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan potassium and Hydrochlorothiazide
losartan potassium and hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Unichem Pharmaceuticals (USA), Inc.	f61b4ffe-cca6-482d-88fa-adf22cb3fff2	2025-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: losartan potassium and hydrochlorothiazide
losartan potassium and hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	eb423f4b-8104-4406-bfc2-8943e517329f	2025-06-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: losartan potassium and hydrochlorothiazide
Losartan potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	352061ee-942d-6cba-e063-6294a90a9eea	2025-06-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan potassium and Hydrochlorothiazide
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	e0f63126-6890-48bf-9c25-444dc5974ecd	2025-02-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium and Hydrochlorothiazide
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	NuCare Pharmaceuticals,Inc.	5e35e3b9-7d79-b32a-e053-2991aa0ae9c0	2025-02-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium and Hydrochlorothiazide
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	8b36fa56-4274-4fc6-bdba-ca7a399b2b21	2025-01-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium and Hydrochlorothiazide
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	b4f5dd93-5f44-4c8c-9e3b-89ab1fa5a7fd	2025-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium and Hydrochlorothiazide
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Direct Rx	d8284747-07b6-9775-e053-2a95a90ad52d	2025-01-21	Warnings, Adverse reactions	Name fallback brand name: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Direct Rx	d88ad738-a915-7679-e053-2a95a90a58c7	2025-01-21	Warnings, Adverse reactions	Name fallback brand name: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	DirectRx	cf4278a3-fbb7-a8ab-e053-2a95a90abc0f	2025-01-20	Warnings, Adverse reactions	Name fallback brand name: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	DirectRx	d1ed9593-a587-55bb-e053-2995a90a8a9a	2025-01-20	Warnings, Adverse reactions	Name fallback brand name: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	DirectRx	d1ee193e-bf78-3134-e053-2a95a90a65d2	2025-01-20	Warnings, Adverse reactions	Name fallback brand name: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	DirectRx	d2021060-94d7-3e1d-e053-2995a90a10ee	2025-01-20	Warnings, Adverse reactions	Name fallback brand name: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Direct_Rx	8de04bf2-83dd-c494-e053-2a95a90abade	2025-01-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Quality Care Products, LLC	a6241e63-1952-4dfa-ba94-c406059501dd	2024-12-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium and Hydrochlorothiazide
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	927315ca-211b-4976-b228-cf544f7e5259	2024-11-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium and Hydrochlorothiazide
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	98b97680-474c-4e70-89dd-15bb49773125	2024-08-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium and Hydrochlorothiazide
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	af44b2b0-1204-43c9-8ec1-d081d35b8f2b	2024-06-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium and Hydrochlorothiazide

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9350	ORIG	2010-04-09