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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 216216


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NDA 216216 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 216216
Tradename:METOLAZONE
Applicant:Ne Rx Pharma
Ingredient:metolazone
Patents:0
Pharmacology for NDA: 216216
Physiological EffectIncreased Diuresis
Medical Subject Heading (MeSH) Categories for 216216
Antihypertensive Agents
Diuretics
Sodium Chloride Symporter Inhibitors
Suppliers and Packaging for NDA: 216216
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METOLAZONE metolazone TABLET;ORAL 216216 ANDA Marlex Pharmaceuticals, Inc. 10135-765 10135-765-01 100 TABLET in 1 BOTTLE (10135-765-01)
METOLAZONE metolazone TABLET;ORAL 216216 ANDA Marlex Pharmaceuticals, Inc. 10135-765 10135-765-10 1000 TABLET in 1 BOTTLE (10135-765-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Oct 25, 2022TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Oct 25, 2022TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Oct 25, 2022TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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