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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 219859

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NDA 219859 describes LOSARTAN POTASSIUM, which is a drug marketed by Aiping Pharm Inc, Alembic Pharms Ltd, Apotex, Apotex Corp, Aurobindo Pharma, Chartwell Rx, Granules, Graviti Pharms, Hetero Labs Ltd V, Hikma, Hisun Pharm Hangzhou, Ipca Labs Ltd, Jubilant Cadista, Lupin Ltd, Macleods Pharms Ltd, Micro Labs, MSN, Mylan, Prinston Inc, Strides Pharma, Teva, Torrent Pharms, Unichem, Watson Labs, Zydus Pharms Usa Inc, and Teva Pharms, and is included in forty-two NDAs. It is available from forty-six suppliers. Additional details are available on the LOSARTAN POTASSIUM profile page.

The generic ingredient in LOSARTAN POTASSIUM is hydrochlorothiazide; losartan potassium. There are thirty-two drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; losartan potassium profile page.

Summary for 219859

Tradename:	LOSARTAN POTASSIUM
Applicant:	Graviti Pharms
Ingredient:	losartan potassium
Patents:	0

Medical Subject Heading (MeSH) Categories for 219859

Angiotensin II Type 1 Receptor Blockers
Anti-Arrhythmia Agents
Antihypertensive Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Sep 19, 2025	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Sep 19, 2025	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Sep 19, 2025	TE:	AB	RLD:	No

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