Details for New Drug Application (NDA): 019888

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NDA 019888 describes ZESTORETIC, which is a drug marketed by Almatica 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-four suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; lisinopril profile page.

Summary for 019888

Tradename:	ZESTORETIC
Applicant:	Almatica
Ingredient:	hydrochlorothiazide; lisinopril
Patents:	0

Pharmacology for NDA: 019888

Mechanism of Action	Angiotensin-converting Enzyme Inhibitors
Physiological Effect	Increased 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:	RX	Dosage:	TABLET;ORAL			Strength	12.5MG;20MG
Approval Date:	Sep 20, 1990	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG;20MG
Approval Date:	Jul 20, 1989	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	12.5MG;10MG
Approval Date:	Nov 18, 1993	TE:	AB	RLD:	Yes

Expired US Patents for NDA 019888

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

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