Application 201170

Type: ANDA
Sponsor: CADISTA PHARMS

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 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
A201170-001	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-09-18
A201170-002	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-09-18
A201170-003	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-09-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201170-001	AB
A201170-002	AB
A201170-003	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	A201170-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201170-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201170-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201170-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201170-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201170-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201170-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201170-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201170-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201170-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201170-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201170-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201170-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201170-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201170-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201170-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201170-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201170-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201170-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201170-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201170-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201170-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201170-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201170-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201170-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201170-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201170-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201170-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-09-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201170-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-09-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201170-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-09-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201170-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-09-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201170-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-09-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201170-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201170-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-09-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201170-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-09-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201170-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-09-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201170-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-09-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201170-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-09-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201170-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-09-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201170-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-09-18	`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	A201170-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201170-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201170-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201170-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201170-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201170-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201170-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201170-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201170-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201170-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201170-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201170-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201170-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201170-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201170-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201170-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201170-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201170-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201170-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201170-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201170-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201170-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201170-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201170-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201170-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201170-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201170-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201170-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201170-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201170-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201170-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201170-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201170-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201170-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201170-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201170-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201170-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201170-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201170-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201170-001	AB	1	`8072bd15b7f6…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Losartan potassium Tablets, 25 mg	LOSARTAN POTASSIUM	Bryant Ranch Prepack	7b8f5329-4fdb-4e1d-98b1-de1ca1b171c5	2025-11-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201170 application number: ANDA201170
Losartan potassium Tablets, 100 mg	LOSARTAN POTASSIUM	Bryant Ranch Prepack	726002cf-2d95-4dac-b1f6-e7f92bb13496	2025-11-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201170 application number: ANDA201170
Losartan potassium Tablets, 50 mg	LOSARTAN POTASSIUM	Bryant Ranch Prepack	d67926b0-c22b-4803-b55d-c98a81389449	2025-11-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201170 application number: ANDA201170
Losartan potassium Tablets, 50 mg	LOSARTAN POTASSIUM	Bryant Ranch Prepack	3d7ddcac-508d-459c-96c8-c62f9c0b5193	2025-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201170 application number: ANDA201170 ndc (product): 71335-1817
Losartan potassium Tablets, 50 mg	LOSARTAN POTASSIUM	Bryant Ranch Prepack	eea03814-3fb5-4f85-8a4d-18e73057d880	2025-09-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201170 application number: ANDA201170 ndc (product): 63629-9192
Losartan potassium Tablets, 100 mg	LOSARTAN POTASSIUM	Bryant Ranch Prepack	04c4ba11-a9bd-4fed-bf14-14214f33f9c2	2025-09-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201170 application number: ANDA201170 ndc (product): 63629-2428
Losartan potassium Tablets, 25 mg	LOSARTAN POTASSIUM	Bryant Ranch Prepack	ee58207e-3913-4262-87ec-930bb4ecf07b	2025-09-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201170 application number: ANDA201170 ndc (product): 63629-2426
Losartan potassium Tablets, 100 mg	LOSARTAN POTASSIUM	Coupler LLC	2d1b03bb-2355-baac-e063-6294a90a9b40	2025-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201170 application number: ANDA201170
Losartan potassium Tablets, 25 mg	LOSARTAN POTASSIUM	Jubilant Cadista Pharmaceuticals Inc.	1bf520a2-a50e-a6ae-0fdf-9be4e69729c0	2024-12-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201170 application number: ANDA201170 ndc (product): 59746-334 ndc (product): 59746-333 ndc (product): 59746-335

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42291-422	Losartan potassium Tablets, 25 mg	losartan potassium	AvKARE, Inc.	ANDA	Current
42291-422	Losartan potassium Tablets, 25 mg	losartan potassium	AvKARE	ANDA	Current
42291-423	Losartan potassium Tablets, 50 mg	losartan potassium	AvKARE, Inc.	ANDA	Current
42291-423	Losartan potassium Tablets, 50 mg	losartan potassium	AvKARE	ANDA	Current
42291-424	Losartan potassium Tablets, 100 mg	losartan potassium	AvKARE, Inc.	ANDA	Current
42291-424	Losartan potassium Tablets, 100 mg	losartan potassium	AvKARE	ANDA	Current
43353-299	Losartan potassium Tablets, 100 mg	losartan potassium	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
59746-333	Losartan potassium Tablets, 25 mg	losartan potassium	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-334	Losartan potassium Tablets, 50 mg	losartan potassium	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-335	Losartan potassium Tablets, 100 mg	losartan potassium	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
63629-2426	Losartan potassium Tablets, 25 mg	losartan potassium	Bryant Ranch Prepack	ANDA	Current
63629-2426	Losartan potassium Tablets, 25 mg	losartan potassium	Bryant Ranch Prepack	ANDA	Current
63629-2427	Losartan potassium Tablets, 50 mg	losartan potassium	Bryant Ranch Prepack	ANDA	Current
63629-2427	Losartan potassium Tablets, 50 mg	losartan potassium	Bryant Ranch Prepack	ANDA	Current
63629-2428	Losartan potassium Tablets, 100 mg	losartan potassium	Bryant Ranch Prepack	ANDA	Current
63629-2428	Losartan potassium Tablets, 100 mg	losartan potassium	Bryant Ranch Prepack	ANDA	Current
63629-9192	Losartan potassium Tablets, 50 mg	losartan potassium	Bryant Ranch Prepack	ANDA	Current
71335-1817	Losartan potassium Tablets, 50 mg	losartan potassium	Bryant Ranch Prepack	ANDA	Current
71610-417	Losartan potassium Tablets, 25 mg	losartan potassium	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-418	Losartan potassium Tablets, 50 mg	losartan potassium	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current