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Details for New Drug Application (NDA): 089534

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NDA 089534 describes SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Mylan, Ascot, Sun Pharm Inds, Superpharm, Mutual Pharm, Sandoz, Watson Labs, and Purepac Pharm, 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. Eight suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; spironolactone profile page.

Summary for NDA: 089534

Tradename:
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
Applicant:
Sun Pharm Inds
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 Mutual Pharmaceutical Company, Inc. 53489-144 53489-144-01 100 TABLET in 1 BOTTLE, PLASTIC (53489-144-01)
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; spironolactone
TABLET;ORAL 089534 ANDA Mutual Pharmaceutical Company, Inc. 53489-144 53489-144-05 500 TABLET in 1 BOTTLE, PLASTIC (53489-144-05)

Summary for product number 001

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


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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