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Generated: May 29, 2017

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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 three suppliers. Additional details are available on the ALDACTAZIDE profile page.

The generic ingredient in ALDACTAZIDE 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: 012616

Formulation / Manufacturing:see details

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
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)
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)

Summary for product number 004

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

Summary for product number 005

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

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