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Last Updated: January 29, 2026

Details for New Drug Application (NDA): 215184

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NDA 215184 describes METOLAZONE, which is a drug marketed by Alembic, Ani Pharms, Innogenix, Ixora Lifescience, 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 are ten drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the metolazone profile page.

Summary for 215184

Tradename:	METOLAZONE
Applicant:	Rubicon Research
Ingredient:	metolazone
Patents:	0

Pharmacology for NDA: 215184

Physiological Effect	Increased Diuresis

Medical Subject Heading (MeSH) Categories for 215184

Antihypertensive Agents
Diuretics
Sodium Chloride Symporter Inhibitors

Suppliers and Packaging for NDA: 215184

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METOLAZONE	metolazone	TABLET;ORAL	215184	ANDA	A-S Medication Solutions	50090-6972	50090-6972-0	30 TABLET in 1 BOTTLE (50090-6972-0)
METOLAZONE	metolazone	TABLET;ORAL	215184	ANDA	Advagen Pharma Limited	72888-052	72888-052-01	100 TABLET in 1 BOTTLE (72888-052-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2.5MG
Approval Date:	Aug 20, 2021	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Aug 20, 2021	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Aug 20, 2021	TE:	AB	RLD:	No

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