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Details for New Drug Application (NDA): 073449

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NDA 073449 describes TRIAMTERENE AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Mylan, Lannett Holdings Inc, Sandoz, Am Therap, Pliva, Vitarine, Watson Labs, Apotex Inc, Duramed Pharms Barr, Novartis, Ivax Sub Teva Pharms, Ani Pharms Inc, and Quantum Pharmics, and is included in nineteen NDAs. It is available from thirty-eight 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-one drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; triamterene profile page.

Summary for NDA: 073449

Tradename:
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
Applicant:
Watson Labs
Ingredient:
hydrochlorothiazide; triamterene
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 073449

Suppliers and Packaging for NDA: 073449

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; triamterene
TABLET;ORAL 073449 ANDA Actavis Pharma, Inc. 0591-0424 0591-0424-01 100 TABLET in 1 BOTTLE, PLASTIC (0591-0424-01)
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; triamterene
TABLET;ORAL 073449 ANDA Actavis Pharma, Inc. 0591-0424 0591-0424-05 500 TABLET in 1 BOTTLE, PLASTIC (0591-0424-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;37.5MG
Approval Date:Sep 23, 1993TE:ABRLD:No


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