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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 215616


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NDA 215616 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 215616
Tradename:METOLAZONE
Applicant:Renata
Ingredient:metolazone
Patents:0
Pharmacology for NDA: 215616
Physiological EffectIncreased Diuresis
Medical Subject Heading (MeSH) Categories for 215616
Antihypertensive Agents
Diuretics
Sodium Chloride Symporter Inhibitors
Suppliers and Packaging for NDA: 215616
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METOLAZONE metolazone TABLET;ORAL 215616 ANDA Major Pharmaceuticals 0904-7520 0904-7520-61 100 BLISTER PACK in 1 CARTON (0904-7520-61) / 1 TABLET in 1 BLISTER PACK
METOLAZONE metolazone TABLET;ORAL 215616 ANDA Major Pharmaceuticals 0904-7521 0904-7521-61 100 BLISTER PACK in 1 CARTON (0904-7521-61) / 1 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Oct 24, 2022TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Oct 24, 2022TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Oct 24, 2022TE:ABRLD:No

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Preferred Citation:

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