Last Updated: September 24, 2026

Details for New Drug Application (NDA): 213827


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NDA 213827 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 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 213827
Tradename:METOLAZONE
Applicant:Innogenix
Ingredient:metolazone
Patents:0
Pharmacology for NDA: 213827
Physiological EffectIncreased Diuresis
Medical Subject Heading (MeSH) Categories for 213827
Antihypertensive Agents
Diuretics
Sodium Chloride Symporter Inhibitors
Suppliers and Packaging for NDA: 213827
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METOLAZONE metolazone TABLET;ORAL 213827 ANDA A-S Medication Solutions 50090-6802 50090-6802-0 30 TABLET in 1 BOTTLE (50090-6802-0)
METOLAZONE metolazone TABLET;ORAL 213827 ANDA Golden State Medical Supply, Inc. 51407-431 51407-431-01 100 TABLET in 1 BOTTLE (51407-431-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Mar 30, 2021TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Mar 30, 2021TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Mar 30, 2021TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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