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Last Updated: July 4, 2020

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Details for New Drug Application (NDA): 201356


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NDA 201356 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: 201356
Mechanism of ActionAngiotensin-converting Enzyme Inhibitors
Physiological EffectIncreased Diuresis
Suppliers and Packaging for NDA: 201356
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; quinapril hydrochloride TABLET;ORAL 201356 ANDA Cipla USA Inc. 69097-828 69097-828-05 90 TABLET in 1 BOTTLE (69097-828-05)
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; quinapril hydrochloride TABLET;ORAL 201356 ANDA Cipla USA Inc. 69097-829 69097-829-05 90 TABLET in 1 BOTTLE (69097-829-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;EQ 10MG BASE
Approval Date:Apr 20, 2011TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;EQ 20MG BASE
Approval Date:Apr 20, 2011TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;EQ 20MG BASE
Approval Date:Apr 20, 2011TE:ABRLD:No

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