Application 204901

Type: ANDA
Sponsor: PRINSTON INC

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 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	TE codes	Approval date
A204901-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM	12.5MG;50MG	TABLET / ORAL	AB	2017-11-06
A204901-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM	12.5MG;100MG	TABLET / ORAL	AB	2017-11-06
A204901-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM	25MG;100MG	TABLET / ORAL	AB	2017-11-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A204901-001	AB
A204901-002	AB
A204901-003	AB

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 · 126 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	A204901-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB	2017-11-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204901-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB	2017-11-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204901-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	2017-11-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204901-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB	2017-11-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204901-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB	2017-11-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204901-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	2017-11-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204901-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB	2017-11-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204901-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB	2017-11-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204901-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	2017-11-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204901-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB	2017-11-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204901-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB	2017-11-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204901-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	2017-11-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204901-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB	2017-11-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204901-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB	2017-11-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204901-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	2017-11-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204901-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB	2017-11-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204901-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB	2017-11-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204901-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	2017-11-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204901-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB	2017-11-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204901-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB	2017-11-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204901-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	2017-11-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204901-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB	2017-11-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204901-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB	2017-11-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204901-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	2017-11-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204901-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB	2017-11-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204901-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB	2017-11-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204901-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	2017-11-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204901-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB	2017-11-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204901-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB	2017-11-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204901-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	2017-11-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204901-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB	2017-11-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204901-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB	2017-11-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204901-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	2017-11-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204901-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB	2017-11-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204901-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB	2017-11-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204901-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	2017-11-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204901-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB	2017-11-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204901-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB	2017-11-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204901-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	2017-11-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204901-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB	2017-11-06	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A204901-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204901-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204901-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204901-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204901-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204901-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204901-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204901-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204901-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204901-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204901-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204901-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204901-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204901-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204901-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204901-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204901-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204901-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204901-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204901-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204901-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204901-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204901-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204901-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204901-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204901-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204901-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204901-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204901-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204901-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204901-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204901-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204901-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204901-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204901-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204901-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204901-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204901-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204901-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204901-001	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 1 · 19 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	REMEDYREPACK INC.	fd07d24c-6db1-4f6b-b226-68abba3a3321	2026-08-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204901 application number: ANDA204901 ndc (product): 70518-3398
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	REMEDYREPACK INC.	446e6998-01f6-4de0-be57-7fecf5448e95	2026-08-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204901 application number: ANDA204901 ndc (product): 70518-3420
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	St. Mary's Medical Park Pharmacy	eac57b4c-e79b-8d35-e053-2a95a90a9d25	2026-06-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204901 application number: ANDA204901 ndc (product): 60760-572
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	QPharma, Inc	499208e5-21ab-d4fe-e063-6294a90a9a78	2026-05-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204901 application number: ANDA204901
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	REMEDYREPACK INC.	03c0ec8d-9daf-43e8-8a4e-a2ddc3573ca7	2026-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204901 application number: ANDA204901
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Direct Rx	d838e918-2463-79f6-e053-2a95a90a948d	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204901 application number: ANDA204901 ndc (product): 72189-327
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Solco Healthcare US, LLC	6d677f9e-c0e4-4d6e-bea2-a58e986e4635	2025-11-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204901 application number: ANDA204901 ndc (product): 43547-424 ndc (product): 43547-423 ndc (product): 43547-425
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Proficient Rx LP	be81ba65-c434-4287-97d3-cd11d6031636	2025-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204901 application number: ANDA204901
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Preferred Pharmaceuticals Inc.	46cf633d-70a5-4d3b-b349-ad74c23ddace	2025-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204901 application number: ANDA204901 ndc (product): 68788-8187
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	e0f63126-6890-48bf-9c25-444dc5974ecd	2025-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204901 application number: ANDA204901
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	8b36fa56-4274-4fc6-bdba-ca7a399b2b21	2025-01-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204901 application number: ANDA204901
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Direct Rx	d8284747-07b6-9775-e053-2a95a90ad52d	2025-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204901 application number: ANDA204901 ndc (product): 72189-325
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Direct Rx	d88ad738-a915-7679-e053-2a95a90a58c7	2025-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204901 application number: ANDA204901 ndc (product): 72189-326
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	Exact identifier application applno (ANDA): 204901 application number: ANDA204901
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	927315ca-211b-4976-b228-cf544f7e5259	2024-11-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204901 application number: ANDA204901
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	Exact identifier application applno (ANDA): 204901 application number: ANDA204901
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Proficient Rx LP	c6ed6f74-0eca-4f99-8c7e-dd3f56167f01	2024-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204901 application number: ANDA204901
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	6bd15e74-2ca2-49c8-8c01-0a647d3fa5df	2024-01-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204901 application number: ANDA204901
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	42942482-1f54-4c7f-9d5f-4aaf20abb3e3	2023-11-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204901 application number: ANDA204901 ndc (product): 71335-2127

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43547-423	Losartan Potassium and Hydrochlorothiazide	losartan potassium and hydrochlorothiazide	Solco Healthcare US, LLC	ANDA	Current
43547-423	Losartan Potassium and Hydrochlorothiazide	losartan potassium and hydrochlorothiazide	Solco Healthcare US, LLC	ANDA	Current
43547-423	Losartan Potassium and Hydrochlorothiazide	losartan potassium and hydrochlorothiazide	Solco Healthcare US, LLC	ANDA	Current
43547-424	Losartan Potassium and Hydrochlorothiazide	losartan potassium and hydrochlorothiazide	Solco Healthcare US, LLC	ANDA	Current
43547-424	Losartan Potassium and Hydrochlorothiazide	losartan potassium and hydrochlorothiazide	Solco Healthcare US, LLC	ANDA	Current
43547-424	Losartan Potassium and Hydrochlorothiazide	losartan potassium and hydrochlorothiazide	Solco Healthcare US, LLC	ANDA	Current
43547-425	Losartan Potassium and Hydrochlorothiazide	losartan potassium and hydrochlorothiazide	Solco Healthcare US, LLC	ANDA	Current
43547-425	Losartan Potassium and Hydrochlorothiazide	losartan potassium and hydrochlorothiazide	Solco Healthcare US, LLC	ANDA	Current
43547-425	Losartan Potassium and Hydrochlorothiazide	losartan potassium and hydrochlorothiazide	Solco Healthcare US, LLC	ANDA	Current
60760-572	Losartan Potassium and Hydrochlorothiazide	losartan potassium and hydrochlorothiazide	ST. MARY'S MEDICAL PARK PHARMACY	ANDA	Current
68071-2785	Losartan Potassium and Hydrochlorothiazide	losartan potassium and hydrochlorothiazide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-8187	Losartan Potassium and Hydrochlorothiazide	losartan potassium and hydrochlorothiazide	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-3398	Losartan Potassium and Hydrochlorothiazide	losartan potassium and hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-3420	Losartan Potassium and Hydrochlorothiazide	losartan potassium and hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-3420	Losartan Potassium and Hydrochlorothiazide	losartan potassium and hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-3420	Losartan Potassium and Hydrochlorothiazide	losartan potassium and hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-3420	Losartan Potassium and Hydrochlorothiazide	losartan potassium and hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-3420	Losartan Potassium and Hydrochlorothiazide	losartan potassium and hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
71335-2127	Losartan Potassium and Hydrochlorothiazide	losartan potassium and hydrochlorothiazide	Bryant Ranch Prepack	ANDA	Current
72189-325	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Direct Rx	ANDA	Current
72189-325	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Direct Rx	ANDA	Current
72189-326	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	losartan potassium and hydrochlorothiazide	Direct Rx	ANDA	Current
72189-326	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	losartan potassium and hydrochlorothiazide	Direct Rx	ANDA	Current
72189-326	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	losartan potassium and hydrochlorothiazide	Direct Rx	ANDA	Current
72189-327	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Direct Rx	ANDA	Current