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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 214611


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NDA 214611 describes TRIAMTERENE AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Ani Pharms, Cadila, Chartwell Rx, Duramed Pharms Barr, Lannett Co Inc, Macleods Pharms Ltd, Novartis, Pharmobedient, Sandoz, Vitarine, Am Therap, Apotex Inc, Pliva, Quantum Pharmics, Rubicon Research, Watson Labs, and Zydus Pharms, and is included in twenty-three NDAs. It is available from twenty-four suppliers. Additional details are available on the TRIAMTERENE AND HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in TRIAMTERENE AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; triamterene. There are thirty-two drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; triamterene profile page.
Summary for 214611
Tradename:TRIAMTERENE AND HYDROCHLOROTHIAZIDE
Applicant:Macleods Pharms Ltd
Ingredient:hydrochlorothiazide; triamterene
Patents:0
Pharmacology for NDA: 214611
Physiological EffectDecreased Renal K+ Excretion
Increased Diuresis
Suppliers and Packaging for NDA: 214611
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRIAMTERENE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; triamterene CAPSULE;ORAL 214611 ANDA Macleods Pharmaceuticals Limited 33342-467 33342-467-11 100 CAPSULE in 1 BOTTLE (33342-467-11)
TRIAMTERENE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; triamterene CAPSULE;ORAL 214611 ANDA Macleods Pharmaceuticals Limited 33342-467 33342-467-44 1000 CAPSULE in 1 BOTTLE (33342-467-44)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength25MG;37.5MG
Approval Date:Jan 28, 2025TE:RLD:No

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Preferred Citation:

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