Details for New Drug Application (NDA): 019778

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NDA 019778 describes PRINZIDE, which is a drug marketed by Merck and is included in one NDA. Additional details are available on the PRINZIDE profile page.

The generic ingredient in PRINZIDE 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 019778

Tradename:	PRINZIDE
Applicant:	Merck
Ingredient:	hydrochlorothiazide; lisinopril
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	12.5MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Feb 16, 1989	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Feb 16, 1989	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	12.5MG;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Nov 18, 1993	TE:		RLD:	Yes

Expired US Patents for NDA 019778

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck	PRINZIDE	hydrochlorothiazide; lisinopril	TABLET;ORAL	019778-002	Feb 16, 1989	4,374,829*PED	⤷ Subscribe
Merck	PRINZIDE	hydrochlorothiazide; lisinopril	TABLET;ORAL	019778-003	Nov 18, 1993	4,374,829*PED	⤷ Subscribe
Merck	PRINZIDE	hydrochlorothiazide; lisinopril	TABLET;ORAL	019778-002	Feb 16, 1989	4,472,380	⤷ Subscribe
Merck	PRINZIDE	hydrochlorothiazide; lisinopril	TABLET;ORAL	019778-001	Feb 16, 1989	4,472,380	⤷ Subscribe
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