Application 090428

Type: ANDA
Sponsor: ALEMBIC 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
A090428-001	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06
A090428-002	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06
A090428-003	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090428-001	AB
A090428-002	AB
A090428-003	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	A090428-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090428-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090428-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090428-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090428-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090428-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090428-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090428-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090428-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090428-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090428-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090428-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090428-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090428-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090428-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090428-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090428-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090428-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090428-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090428-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090428-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090428-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090428-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090428-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090428-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090428-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090428-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090428-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090428-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090428-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090428-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090428-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090428-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090428-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090428-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090428-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090428-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090428-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2010-10-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090428-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2010-10-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090428-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2010-10-06	`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	A090428-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090428-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090428-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090428-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090428-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090428-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090428-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090428-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090428-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090428-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090428-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090428-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090428-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090428-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090428-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090428-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090428-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090428-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090428-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090428-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090428-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090428-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090428-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090428-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090428-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090428-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090428-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090428-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090428-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090428-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090428-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090428-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090428-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090428-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090428-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090428-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090428-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090428-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090428-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090428-001	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Losartan Potassium	LOSARTAN POTASSIUM	Alembic Pharmaceuticals Limited	eeb77c84-38d3-432d-914a-54b312b374bd	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090428 application number: ANDA090428 ndc (product): 46708-446 ndc (product): 46708-447 ndc (product): 46708-445
Losartan Potassium	LOSARTAN POTASSIUM	Alembic Pharmaceuticals Inc.	1dadbe02-289c-4312-9e65-40f3314dcc31	2025-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090428 application number: ANDA090428 ndc (product): 62332-027 ndc (product): 62332-029 ndc (product): 62332-028

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
46708-445	Losatan Potassium	Losatan Potassium	Alembic Pharmaceuticals Limited	ANDA	Current
46708-445	Losartan Potassium	Losartan Potassium	Alembic Pharmaceuticals Limited	ANDA	Current
46708-445	Losatan Potassium	Losatan Potassium	Alembic Pharmaceuticals Limited	ANDA	Current
46708-446	Losatan Potassium	Losatan Potassium	Alembic Pharmaceuticals Limited	ANDA	Current
46708-446	Losartan Potassium	Losartan Potassium	Alembic Pharmaceuticals Limited	ANDA	Current
46708-446	Losatan Potassium	Losatan Potassium	Alembic Pharmaceuticals Limited	ANDA	Current
46708-447	Losatan Potassium	Losatan Potassium	Alembic Pharmaceuticals Limited	ANDA	Current
46708-447	Losartan Potassium	Losartan Potassium	Alembic Pharmaceuticals Limited	ANDA	Current
46708-447	Losatan Potassium	Losatan Potassium	Alembic Pharmaceuticals Limited	ANDA	Current
51655-258	Losatan Potassium	Losatan Potassium	Northwind Pharmaceuticals	ANDA	Current
53808-0892	Losartan Potassium	Losartan Potassium	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0896	Losartan Potassium	Losartan Potassium	State of Florida DOH Central Pharmacy	ANDA	Current
62332-027	Losartan Potassium	Losartan Potassium	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-027	Losartan Potassium	Losartan Potassium	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-027	Losartan Potassium	Losartan Potassium	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-027	Losatan Potassium	Losatan Potassium	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-028	Losartan Potassium	Losartan Potassium	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-028	Losartan Potassium	Losartan Potassium	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-028	Losartan Potassium	Losartan Potassium	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-028	Losatan Potassium	Losatan Potassium	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-029	Losartan Potassium	Losartan Potassium	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-029	Losartan Potassium	Losartan Potassium	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-029	Losartan Potassium	Losartan Potassium	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-029	Losatan Potassium	Losatan Potassium	Alembic Pharmaceuticals Inc.	ANDA	Current
63187-316	Losartan Potassium	Losartan Potassium	Proficient Rx LP	ANDA	Current
64205-225	Losartan Potassium	Losartan Potassium	ReadyMeds	ANDA	Current
64205-226	Losartan Potassium	Losartan Potassium	ReadyMeds	ANDA	Current
70518-0862	Losatan Potassium	Losatan Potassium	REMEDYREPACK INC.	ANDA	Current
70518-0862	Losatan Potassium	Losatan Potassium	REMEDYREPACK INC.	ANDA	Current
70518-3305	Losartan Potassium	Losartan Potassium	REMEDYREPACK INC.	ANDA	Current
70518-3305	Losartan Potassium	Losartan Potassium	REMEDYREPACK INC.	ANDA	Current