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Last Updated: August 13, 2020

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Details for New Drug Application (NDA): 019888

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NDA 019888 describes ZESTORETIC, which is a drug marketed by Alvogen and is included in one NDA. It is available from one supplier. Additional details are available on the ZESTORETIC profile page.

The generic ingredient in ZESTORETIC is hydrochlorothiazide; lisinopril. There are thirty-two drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; lisinopril profile page.
Summary for 019888
Tradename:ZESTORETIC
Applicant:Alvogen
Ingredient:hydrochlorothiazide; lisinopril
Patents:0
Pharmacology for NDA: 019888
Mechanism of ActionAngiotensin-converting Enzyme Inhibitors
Physiological EffectIncreased Diuresis
Suppliers and Packaging for NDA: 019888
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZESTORETIC hydrochlorothiazide; lisinopril TABLET;ORAL 019888 NDA Almatica Pharma Inc. 52427-435 52427-435-90 90 TABLET in 1 BOTTLE (52427-435-90)
ZESTORETIC hydrochlorothiazide; lisinopril TABLET;ORAL 019888 NDA Almatica Pharma Inc. 52427-436 52427-436-90 90 TABLET in 1 BOTTLE (52427-436-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;20MG
Approval Date:Sep 20, 1990TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;20MG
Approval Date:Jul 20, 1989TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;10MG
Approval Date:Nov 18, 1993TE:ABRLD:Yes

Expired US Patents for NDA 019888

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alvogen ZESTORETIC hydrochlorothiazide; lisinopril TABLET;ORAL 019888-002 Jul 20, 1989   Start Trial   Start Trial
Alvogen ZESTORETIC hydrochlorothiazide; lisinopril TABLET;ORAL 019888-003 Nov 18, 1993   Start Trial   Start Trial
Alvogen ZESTORETIC hydrochlorothiazide; lisinopril TABLET;ORAL 019888-001 Sep 20, 1990   Start Trial   Start Trial
Alvogen ZESTORETIC hydrochlorothiazide; lisinopril TABLET;ORAL 019888-003 Nov 18, 1993   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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