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Last Updated: October 17, 2021

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Details for New Drug Application (NDA): 211581

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NDA 211581 describes TRIAMTERENE, which is a drug marketed by Agnitio, Ani Pharms, Cadila, Chartwell Rx, Duramed Pharms Barr, Lannett Co Inc, Mylan, Novartis, Sandoz, Vitarine, Am Therap, Apotex Inc, Pliva, Quantum Pharmics, Watson Labs, and Zydus Pharms, and is included in twenty-two NDAs. It is available from one supplier. Additional details are available on the TRIAMTERENE profile page.

The generic ingredient in TRIAMTERENE is hydrochlorothiazide; triamterene. There are thirty-two drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; triamterene profile page.
Summary for 211581
Formulation / Manufacturing:see details
Pharmacology for NDA: 211581
Medical Subject Heading (MeSH) Categories for 211581
Suppliers and Packaging for NDA: 211581
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRIAMTERENE triamterene CAPSULE;ORAL 211581 ANDA TRUPHARMA LLC 52817-364 52817-364-10 100 CAPSULE in 1 BOTTLE (52817-364-10)
TRIAMTERENE triamterene CAPSULE;ORAL 211581 ANDA TRUPHARMA LLC 52817-365 52817-365-10 100 CAPSULE in 1 BOTTLE (52817-365-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Aug 19, 2019TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Aug 19, 2019TE:ABRLD:No

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