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Generated: December 11, 2018

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Details for New Drug Application (NDA): 012616

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NDA 012616 describes ALDACTAZIDE, which is a drug marketed by Gd Searle Llc and is included in one NDA. It is available from two suppliers. Additional details are available on the ALDACTAZIDE profile page.

The generic ingredient in ALDACTAZIDE is hydrochlorothiazide; spironolactone. There are thirty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; spironolactone profile page.
Summary for 012616
Tradename:ALDACTAZIDE
Applicant:Gd Searle Llc
Ingredient:hydrochlorothiazide; spironolactone
Patents:0
Pharmacology for NDA: 012616
Mechanism of ActionAldosterone Antagonists
Physiological EffectIncreased Diuresis
Suppliers and Packaging for NDA: 012616
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALDACTAZIDE hydrochlorothiazide; spironolactone TABLET;ORAL 012616 NDA G.D. Searle LLC Division of Pfizer Inc 0025-1011 0025-1011-31 100 TABLET, FILM COATED in 1 BOTTLE (0025-1011-31)
ALDACTAZIDE hydrochlorothiazide; spironolactone TABLET;ORAL 012616 NDA G.D. Searle LLC Division of Pfizer Inc 0025-1021 0025-1021-31 100 TABLET, FILM COATED in 1 BOTTLE (0025-1021-31)

Profile for product number 004

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;25MG
Approval Date:Dec 30, 1982TE:ABRLD:Yes

Profile for product number 005

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG;50MG
Approval Date:Dec 30, 1982TE:RLD:Yes

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