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Generated: November 20, 2018

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Details for New Drug Application (NDA): 020504

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NDA 020504 describes MICROZIDE, which is a drug marketed by Allergan Sales Llc and is included in one NDA. It is available from eleven suppliers. Additional details are available on the MICROZIDE profile page.

The generic ingredient in MICROZIDE is hydrochlorothiazide. There are thirty-two drug master file entries for this compound. Seventy-six suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide profile page.
Summary for 020504
Tradename:MICROZIDE
Applicant:Allergan Sales Llc
Ingredient:hydrochlorothiazide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020504
Ingredient-typeThiazides
Physiological EffectIncreased Diuresis
Medical Subject Heading (MeSH) Categories for 020504
Suppliers and Packaging for NDA: 020504
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MICROZIDE hydrochlorothiazide CAPSULE;ORAL 020504 NDA AUTHORIZED GENERIC Actavis Pharma, Inc. 0591-0347 0591-0347-00 28085 CAPSULE, GELATIN COATED in 1 PACKAGE (0591-0347-00)
MICROZIDE hydrochlorothiazide CAPSULE;ORAL 020504 NDA AUTHORIZED GENERIC Actavis Pharma, Inc. 0591-0347 0591-0347-01 100 CAPSULE, GELATIN COATED in 1 BOTTLE (0591-0347-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength12.5MG
Approval Date:Dec 27, 1996TE:ABRLD:Yes

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