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Last Updated: January 21, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091524

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NDA 091524 describes QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Apotex Corp, Aurobindo Pharma, Invagen Pharms, Mylan, and Sun Pharm Inds Ltd, and is included in five NDAs. It is available from four suppliers. Additional details are available on the QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; quinapril hydrochloride. There are thirty-two drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; quinapril hydrochloride profile page.
Pharmacology for NDA: 091524
Mechanism of ActionAngiotensin-converting Enzyme Inhibitors
Physiological EffectIncreased Diuresis
Suppliers and Packaging for NDA: 091524
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; quinapril hydrochloride TABLET;ORAL 091524 ANDA Apotex Corp 60505-3409 60505-3409-3 30 TABLET, FILM COATED in 1 BOTTLE (60505-3409-3)
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; quinapril hydrochloride TABLET;ORAL 091524 ANDA Apotex Corp 60505-3409 60505-3409-5 500 TABLET, FILM COATED in 1 BOTTLE (60505-3409-5)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;EQ 10MG BASE
Approval Date:Mar 12, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;EQ 20MG BASE
Approval Date:Mar 12, 2013TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;EQ 20MG BASE
Approval Date:Mar 12, 2013TE:ABRLD:No

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