Application 202230

Type: ANDA
Sponsor: MACLEODS PHARMS LTD

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 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
A202230-001	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-05-30
A202230-002	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-05-30
A202230-003	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-05-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202230-001	AB
A202230-002	AB
A202230-003	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	A202230-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-05-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202230-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-05-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202230-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-05-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202230-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202230-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202230-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-05-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202230-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-05-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202230-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-05-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202230-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-05-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202230-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-05-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202230-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-05-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202230-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-05-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202230-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-05-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202230-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-05-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202230-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-05-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202230-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-05-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202230-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-05-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202230-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-05-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202230-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-05-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202230-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-05-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202230-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-05-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202230-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-05-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202230-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-05-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202230-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-05-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202230-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-05-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202230-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-05-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202230-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-05-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202230-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-05-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202230-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-05-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202230-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-05-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202230-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-05-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202230-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-05-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202230-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-05-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202230-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-05-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202230-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-05-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202230-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-05-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202230-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-05-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202230-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-05-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202230-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-05-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202230-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-05-30	`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	A202230-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202230-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202230-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202230-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202230-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202230-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202230-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202230-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202230-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202230-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202230-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202230-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202230-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202230-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202230-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202230-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202230-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202230-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202230-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202230-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202230-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202230-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202230-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202230-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202230-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202230-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202230-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202230-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202230-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202230-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202230-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202230-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202230-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202230-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202230-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202230-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202230-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202230-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202230-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202230-001	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Losartan potassium	LOSARTAN POTASSIUM	Preferred Pharmaceuticals Inc.	628d0317-b844-42a0-9c27-48e1e23a38f5	2026-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202230 application number: ANDA202230
Losartan potassium	LOSARTAN POTASSIUM	REMEDYREPACK INC.	a397502e-abe7-49cf-97c7-d53a616947eb	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202230 application number: ANDA202230
Losartan potassium	LOSARTAN POTASSIUM	Macleods Pharmaceuticals Limited	85d69d02-c5ef-467e-94aa-903100218795	2025-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202230 application number: ANDA202230 ndc (product): 33342-044 ndc (product): 33342-045 ndc (product): 33342-046
Losartan potassium	LOSARTAN POTASSIUM	Coupler LLC	2d1b1648-8b24-cf4f-e063-6294a90afdd8	2025-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202230 application number: ANDA202230

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
33342-044	Losartan potassium	Losartan potassium	Macleods Pharmaceuticals Limited	ANDA	Current
33342-044	Losartan potassium	Losartan potassium	Macleods Pharmaceuticals Limited	ANDA	Current
33342-045	Losartan potassium	Losartan potassium	Macleods Pharmaceuticals Limited	ANDA	Current
33342-045	Losartan potassium	Losartan potassium	Macleods Pharmaceuticals Limited	ANDA	Current
33342-046	Losartan potassium	Losartan potassium	Macleods Pharmaceuticals Limited	ANDA	Current
33342-046	Losartan potassium	Losartan potassium	Macleods Pharmaceuticals Limited	ANDA	Current
68071-4036	Losartan potassium	Losartan potassium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4062	Losartan potassium	Losartan potassium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4244	Losartan potassium	Losartan potassium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4248	Losartan potassium	Losartan potassium	NuCare Pharmaceuticals,Inc.	ANDA	Current
70934-932	Losartan potassium	Losartan potassium	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current