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Serving leading biopharmaceutical companies globally:

Cipla
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Federal Trade Commission
McKinsey
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Medtronic
Daiichi Sankyo
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Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 089534

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NDA 089534 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 089534
Tradename:SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
Applicant:Sun Pharm Industries
Ingredient:hydrochlorothiazide; spironolactone
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 089534
Ingredient-typeThiazides
Mechanism of ActionAldosterone Antagonists
Physiological EffectIncreased Diuresis
Suppliers and Packaging for NDA: 089534
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; spironolactone TABLET;ORAL 089534 ANDA Sun Pharmaceutical Industries, Inc. 53489-144 53489-144-01 100 TABLET in 1 BOTTLE, PLASTIC (53489-144-01)
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; spironolactone TABLET;ORAL 089534 ANDA Sun Pharmaceutical Industries, Inc. 53489-144 53489-144-10 1000 TABLET in 1 BOTTLE, PLASTIC (53489-144-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;25MG
Approval Date:Jul 2, 1987TE:ABRLD:No

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Baxter
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