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Chinese Patent Office
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Cipla
Moodys
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Generated: January 17, 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, Sandoz, Sun Pharm Industries, Superpharm, and Watson Labs, and is included in eight NDAs. It is available from five 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-one drug master file entries for this compound. Seven 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 0378-0141-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-0141-01)
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; spironolactone TABLET;ORAL 086513 ANDA Mylan Pharmaceuticals Inc. 0378-0141 0378-0141-05 500 TABLET in 1 BOTTLE, PLASTIC (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 leading biopharmaceutical companies globally:

Medtronic
Merck
Harvard Business School
Novartis
QuintilesIMS
Julphar
Accenture
Daiichi Sankyo
AstraZeneca

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