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Generated: August 15, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 071111

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NDA 071111 describes AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Barr, Mylan, Teva, Watson Labs, and Yaopharma Co Ltd, and is included in five NDAs. It is available from three suppliers. Additional details are available on the AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE is amiloride hydrochloride; hydrochlorothiazide. There are five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the amiloride hydrochloride; hydrochlorothiazide profile page.
Summary for 071111
Tradename:AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Applicant:Barr
Ingredient:amiloride hydrochloride; hydrochlorothiazide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 071111
Suppliers and Packaging for NDA: 071111
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE amiloride hydrochloride; hydrochlorothiazide TABLET;ORAL 071111 ANDA Teva Pharmaceuticals USA, Inc. 0555-0483 N 0555-0483-02
AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE amiloride hydrochloride; hydrochlorothiazide TABLET;ORAL 071111 ANDA Teva Pharmaceuticals USA, Inc. 0555-0483 N 0555-0483-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG ANHYDROUS;50MG
Approval Date:May 10, 1988TE:ABRLD:No

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