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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 216211


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NDA 216211 describes TRIAMTERENE AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Ani Pharms, Cadila, Chartwell Rx, Duramed Pharms Barr, Lannett Co Inc, Norvium Bioscience, Novartis, Sandoz, Vitarine, Am Therap, Apotex Inc, Pliva, Quantum Pharmics, Rubicon, Watson Labs, and Zydus Pharms, and is included in twenty-two NDAs. It is available from twenty-nine 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-nine suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; triamterene profile page.
Summary for 216211
Pharmacology for NDA: 216211
Suppliers and Packaging for NDA: 216211
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRIAMTERENE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; triamterene TABLET;ORAL 216211 ANDA Preferred Pharmaceuticals Inc. 68788-8624 68788-8624-1 100 TABLET in 1 BOTTLE (68788-8624-1)
TRIAMTERENE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; triamterene TABLET;ORAL 216211 ANDA Preferred Pharmaceuticals Inc. 68788-8624 68788-8624-3 30 TABLET in 1 BOTTLE (68788-8624-3)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;37.5MG
Approval Date:Feb 23, 2022TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG;75MG
Approval Date:Feb 23, 2022TE:ABRLD:No

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