Application 202289

Type: ANDA
Sponsor: MACLEODS PHARMS LTD

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 1.

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
A202289-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM	12.5MG;50MG	TABLET / ORAL	AB	2012-08-09
A202289-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM	12.5MG;100MG	TABLET / ORAL	AB	2012-08-09
A202289-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM	25MG;100MG	TABLET / ORAL	AB	2012-08-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202289-001	AB
A202289-002	AB
A202289-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	A202289-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB	2012-08-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202289-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB	2012-08-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202289-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	2012-08-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202289-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB	2012-08-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202289-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB	2012-08-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202289-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	2012-08-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202289-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB	2012-08-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202289-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB	2012-08-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202289-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	2012-08-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202289-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB	2012-08-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202289-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB	2012-08-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202289-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	2012-08-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202289-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB	2012-08-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202289-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB	2012-08-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202289-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	2012-08-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202289-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB	2012-08-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202289-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB	2012-08-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202289-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	2012-08-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202289-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB	2012-08-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202289-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB	2012-08-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202289-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	2012-08-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202289-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB	2012-08-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202289-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB	2012-08-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202289-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	2012-08-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202289-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB	2012-08-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202289-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB	2012-08-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202289-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	2012-08-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202289-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB	2012-08-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202289-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB	2012-08-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202289-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	2012-08-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202289-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB	2012-08-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202289-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB	2012-08-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202289-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	2012-08-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202289-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB	2012-08-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202289-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB	2012-08-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202289-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	2012-08-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202289-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB	2012-08-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202289-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB	2012-08-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202289-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	2012-08-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202289-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB	2012-08-09	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202289-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202289-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202289-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202289-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202289-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202289-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202289-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202289-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202289-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202289-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202289-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202289-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202289-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202289-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202289-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202289-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202289-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202289-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202289-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202289-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202289-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202289-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202289-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202289-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202289-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202289-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202289-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202289-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202289-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202289-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202289-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202289-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202289-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202289-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202289-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202289-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202289-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202289-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202289-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202289-001	AB	1	`8072bd15b7f6…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 6 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	Bryant Ranch Prepack	f5f462c6-0604-49d3-af8f-fecbde23be99	2025-12-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202289 application number: ANDA202289
Losartan potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Macleods Pharmaceuticals Limited	a04b5622-2c49-4d61-92b1-5dc523af7a24	2025-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202289 application number: ANDA202289 ndc (product): 33342-051 ndc (product): 33342-052 ndc (product): 33342-050
Losartan potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	352061ee-942d-6cba-e063-6294a90a9eea	2025-06-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202289 application number: ANDA202289
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	DirectRx	d1ed9593-a587-55bb-e053-2995a90a8a9a	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202289 application number: ANDA202289 ndc (product): 72189-289
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	DirectRx	d1ee193e-bf78-3134-e053-2a95a90a65d2	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202289 application number: ANDA202289 ndc (product): 72189-290
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	DirectRx	d2021060-94d7-3e1d-e053-2995a90a10ee	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202289 application number: ANDA202289 ndc (product): 72189-297

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
33342-050	Losartan potassium and Hydrochlorothiazide	Losartan potassium and Hydrochlorothiazide	Macleods Pharmaceuticals Limited	ANDA	Current
33342-050	Losartan potassium and Hydrochlorothiazide	Losartan potassium and Hydrochlorothiazide	Macleods Pharmaceuticals Limited	ANDA	Current
33342-050	Losartan potassium and Hydrochlorothiazide	Losartan potassium and Hydrochlorothiazide	Macleods Pharmaceuticals Limited	ANDA	Current
33342-051	Losartan potassium and Hydrochlorothiazide	Losartan potassium and Hydrochlorothiazide	Macleods Pharmaceuticals Limited	ANDA	Current
33342-051	Losartan potassium and Hydrochlorothiazide	Losartan potassium and Hydrochlorothiazide	Macleods Pharmaceuticals Limited	ANDA	Current
33342-051	Losartan potassium and Hydrochlorothiazide	Losartan potassium and Hydrochlorothiazide	Macleods Pharmaceuticals Limited	ANDA	Current
33342-052	Losartan potassium and Hydrochlorothiazide	Losartan potassium and Hydrochlorothiazide	Macleods Pharmaceuticals Limited	ANDA	Current
33342-052	Losartan potassium and Hydrochlorothiazide	Losartan potassium and Hydrochlorothiazide	Macleods Pharmaceuticals Limited	ANDA	Current
33342-052	Losartan potassium and Hydrochlorothiazide	Losartan potassium and Hydrochlorothiazide	Macleods Pharmaceuticals Limited	ANDA	Current
70518-3231	Losartan potassium and Hydrochlorothiazide	Losartan potassium and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
72189-289	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	DirectRx	ANDA	Current
72189-290	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	DirectRx	ANDA	Current
72189-297	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	DirectRx	ANDA	Current