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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Chubb
US Army
Cantor Fitzgerald
Argus Health
Harvard Business School
Dow
Teva
Medtronic

Generated: May 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 086513

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NDA 086513 describes SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Ascot, Mutual Pharm, Mylan, Purepac Pharm, Sun Pharm Industries, Superpharm, Watson Labs, and Yaopharma Co Ltd, and is included in eight NDAs. It is available from four suppliers. Additional details are available on the SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; spironolactone. There are thirty-two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; spironolactone profile page.
Summary for 086513
Tradename:SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
Applicant:Mylan
Ingredient:hydrochlorothiazide; spironolactone
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 086513
Ingredient-typeThiazides
Mechanism of ActionAldosterone Antagonists
Physiological EffectIncreased Diuresis
Suppliers and Packaging for NDA: 086513
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; spironolactone TABLET;ORAL 086513 ANDA Mylan Pharmaceuticals Inc. 0378-0141 N 0378-0141-01
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; spironolactone TABLET;ORAL 086513 ANDA Mylan Pharmaceuticals Inc. 0378-0141 N 0378-0141-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;25MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Medtronic
US Army
Cipla
Accenture
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Chinese Patent Office
UBS
Mallinckrodt

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