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Generated: October 22, 2018

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Details for New Drug Application (NDA): 071251

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NDA 071251 describes TRIAMTERENE AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Ani Pharms Inc, Casi Pharms Inc, Duramed Pharms Barr, Ivax Sub Teva Pharms, Lannett Co Inc, Mylan, Novartis, Sandoz, Vitarine, Am Therap, Apotex Inc, Pliva, Quantum Pharmics, Watson Labs, and Zydus Pharms Usa Inc, and is included in twenty NDAs. It is available from thirty-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. Forty-three suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; triamterene profile page.
Summary for 071251
Pharmacology for NDA: 071251
Suppliers and Packaging for NDA: 071251
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRIAMTERENE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; triamterene TABLET;ORAL 071251 ANDA Aidarex Pharmaceuticals LLC 33261-952 33261-952-30 30 TABLET in 1 BOTTLE, PLASTIC (33261-952-30)
TRIAMTERENE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; triamterene TABLET;ORAL 071251 ANDA Aidarex Pharmaceuticals LLC 33261-952 33261-952-60 60 TABLET in 1 BOTTLE, PLASTIC (33261-952-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG;75MG
Approval Date:Apr 17, 1988TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;37.5MG
Approval Date:May 5, 1998TE:ABRLD:No

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