Application 219859

Type: ANDA
Sponsor: GRAVITI 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 43.

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
A219859-001	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2025-09-19
A219859-002	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2025-09-19
A219859-003	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2025-09-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A219859-001	AB
A219859-002	AB
A219859-003	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A219859-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2025-09-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219859-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2025-09-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219859-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2025-09-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A219859-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2025-09-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219859-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2025-09-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219859-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2025-09-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A219859-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2025-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219859-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2025-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219859-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2025-09-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219859-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2025-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219859-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2025-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219859-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2025-09-19	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219859-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2025-09-19	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219859-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2025-09-19	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219859-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2025-09-19	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A219859-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219859-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219859-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A219859-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219859-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219859-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A219859-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219859-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219859-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219859-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219859-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219859-003	AB	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219859-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219859-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219859-003	AB	1	`a50c72e98297…`

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 6 of 7 · 137 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	Jubilant Cadista Pharmaceuticals Inc.	1bf520a2-a50e-a6ae-0fdf-9be4e69729c0	2024-12-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Bryant Ranch Prepack	43fa4762-cc0c-4a3b-a527-6aa7fb7c5464	2024-08-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	A-S Medication Solutions	f68fd1a2-1cbf-47c8-b8c4-df49cf17540e	2024-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Bryant Ranch Prepack	de987691-f659-45ab-9c53-402ef7421f4b	2024-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Proficient Rx LP	4b298291-4251-4af8-a436-58a3443a7978	2024-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
LOSARTAN POTASSIUM 100 mg	LOSARTAN POTASSIUM	NuCare Pharmaceuticals,Inc.	a955160f-3c2d-3366-e053-2a95a90a65ea	2024-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	NuCare Pharmaceuticals,Inc.	aa58c629-f7d9-a6e0-e053-2995a90ac188	2024-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	NuCare Pharmaceuticals,iNc.	54b363c4-00bb-08db-e054-00144ff8d46c	2024-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	NuCare Pharmaceuticals,Inc.	9c0809dc-cbdd-1a33-e053-2995a90a4825	2024-06-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	NuCare Pharmaceuticals,Inc.	9f1c20aa-2028-412d-e053-2995a90a1368	2024-06-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	NuCare Pharmaceuticals,Inc.	a11075f1-f7d0-0c3d-e053-2995a90a0c9d	2024-06-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	NuCare Pharmaceuticals,Inc.	a1123700-f4c7-2b62-e053-2a95a90a87d6	2024-06-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	NuCare Pharmaceuticals,Inc.	9130921b-02f0-82d6-e053-2995a90a9c0a	2024-06-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	NuCare Pharmaceuticals,Inc.	91305ca4-7d56-2052-e053-2995a90a5d61	2024-06-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	NuCare Pharmaceuticals,Inc.	97a50b38-f5b3-0a96-e053-2995a90a345f	2024-06-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	NuCare Pharmaceuticals,Inc.	8c2b3412-254b-8fa9-e053-2a95a90a7dc6	2024-06-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	NuCare Pharmaceuticals,Inc.	6eec2a4c-6b5c-11a5-e053-2991aa0aa56b	2024-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	A-S Medication Solutions	cff0c9eb-fafd-48e7-a053-036b676bf57d	2023-10-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	A-S Medication Solutions	679be0b9-bb60-4970-ad50-0041a6d67bf8	2023-03-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	A-S Medication Solutions	0e0a06f3-b8bd-4178-a519-ed80362e33c2	2023-03-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.