Last Updated: November 13, 2026

Details for New Drug Application (NDA): 218606

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NDA 218606 describes METOLAZONE, which is a drug marketed by Acertis Pharms, Alembic, Ani Pharms, Innogenix, Micro Labs, Mylan, Ne Rx Pharma, Renata, Roxane, Rubicon Research, Sandoz, Unichem, and Watson Labs, and is included in fourteen NDAs. It is available from nineteen suppliers. Additional details are available on the METOLAZONE profile page.

The generic ingredient in METOLAZONE is metolazone. There is one drug master file entry for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the metolazone profile page.

Summary for 218606

Tradename:	METOLAZONE
Applicant:	Acertis Pharms
Ingredient:	metolazone
Patents:	0

Medical Subject Heading (MeSH) Categories for 218606

Antihypertensive Agents
Diuretics
Sodium Chloride Symporter Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2.5MG
Approval Date:	Apr 17, 2024	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Apr 17, 2024	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Apr 17, 2024	TE:	AB	RLD:	No

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