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 3 of 7 · 137 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Losartan potassium	LOSARTAN POTASSIUM	Novadoz Pharmaceuticals LLC	5edb843a-66ed-4950-9ed0-393e6a5d7c99	2026-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan potassium generic name: LOSARTAN POTASSIUM
LOSARTAN POTASSIUM 25 mg	LOSARTAN POTASSIUM	Strides Pharma Science Limited	a8817f22-8478-49b9-8354-ab27ca222c6b	2026-01-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOSARTAN POTASSIUM
COZAAR	LOSARTAN POTASSIUM	Organon LLC	9949448f-c3b9-44ee-94ed-c1aca8c90f39	2026-01-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Lupin Pharmaceuticals, Inc.	e5886220-43b7-46e1-9034-5242ba245bd1	2026-01-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Zydus Lifesciences Limited	9ccd6823-e813-472c-99cd-c6ef25e74bed	2026-01-12		Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Quallent Pharmaceuticals Health LLC	1a9e1ffd-edf1-4e35-a7f5-ca351c507d7f	2026-01-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losortan Potassium	LOSARTAN POTASSIUM	AvPAK	a6cd0b5f-2bd6-bed9-e053-2995a90a3191	2026-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOSARTAN POTASSIUM
LOSARTAN POTASSIUM 50 mg	LOSARTAN POTASSIUM	Northwind Health Company, LLC	c29d999d-adc9-6c66-e053-2995a90a1fc3	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Northwind Health Company, LLC	d9ced981-d791-6600-e053-2995a90ace3b	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Northwind Health Company, LLC	d9de3627-9aa2-65c8-e053-2995a90ab5ec	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Northwind Health Company, LLC	d9df33c8-4ea7-5d1c-e053-2a95a90aecf7	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	Northwind Health Company, LLC	d9dfae69-9ce7-0c6b-e053-2a95a90aace8	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	QPharma, Inc.	0c9f3e8c-eafb-4be4-aca5-1d5aa3d7d738	2025-12-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	QPharma, Inc.	c80b36c2-fa22-e7a9-e053-2a95a90ae21e	2025-12-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	QPharma, Inc.	c80b3a28-ef15-5902-e053-2995a90a06d7	2025-12-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	QPharma, Inc.	2a7513c4-b73b-46fe-ba86-6e58658cdbc7	2025-12-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	QPharma, Inc.	16a6a582-eb4d-41bc-9d49-fc1d4117b29a	2025-12-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN POTASSIUM	AiPing Pharmaceutical, Inc.	1ae817aa-5221-4387-a457-306785140741	2025-12-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium generic name: LOSARTAN POTASSIUM
Losartan Potassium	LOSARTAN	Granules Pharmaceuticals Inc.	ca012edc-923d-4ada-a261-db82b71b3c4f	2025-12-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Losartan Potassium
Losartan Potassium	LOSARTAN POTASSIUM	A-S Medication Solutions	67ffab1a-9e80-48dd-a6c6-1b586161fe50	2025-11-26	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.