Details for New Drug Application (NDA): 020125

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NDA 020125 describes ACCURETIC, which is a drug marketed by Pfizer Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the ACCURETIC profile page.

The generic ingredient in ACCURETIC is hydrochlorothiazide; quinapril hydrochloride. There are thirty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; quinapril hydrochloride profile page.

Summary for 020125

Tradename:	ACCURETIC
Applicant:	Pfizer Pharms
Ingredient:	hydrochlorothiazide; quinapril hydrochloride
Patents:	0

Pharmacology for NDA: 020125

Mechanism of Action	Angiotensin-converting Enzyme Inhibitors
Physiological Effect	Increased Diuresis

Suppliers and Packaging for NDA: 020125

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACCURETIC	hydrochlorothiazide; quinapril hydrochloride	TABLET;ORAL	020125	NDA	Parke-Davis Div of Pfizer Inc	0071-3112	0071-3112-23	90 TABLET, FILM COATED in 1 BOTTLE (0071-3112-23)
ACCURETIC	hydrochlorothiazide; quinapril hydrochloride	TABLET;ORAL	020125	NDA	Parke-Davis Div of Pfizer Inc	0071-5212	0071-5212-23	90 TABLET, FILM COATED in 1 BOTTLE (0071-5212-23)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	12.5MG;EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 28, 1999	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	12.5MG;EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 28, 1999	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG;EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 28, 1999	TE:		RLD:	Yes

Expired US Patents for NDA 020125

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer Pharms	ACCURETIC	hydrochlorothiazide; quinapril hydrochloride	TABLET;ORAL	020125-001	Dec 28, 1999	⤷ Sign Up	⤷ Sign Up
Pfizer Pharms	ACCURETIC	hydrochlorothiazide; quinapril hydrochloride	TABLET;ORAL	020125-002	Dec 28, 1999	⤷ Sign Up	⤷ Sign Up
Pfizer Pharms	ACCURETIC	hydrochlorothiazide; quinapril hydrochloride	TABLET;ORAL	020125-003	Dec 28, 1999	⤷ Sign Up	⤷ Sign Up
Pfizer Pharms	ACCURETIC	hydrochlorothiazide; quinapril hydrochloride	TABLET;ORAL	020125-003	Dec 28, 1999	⤷ Sign Up	⤷ Sign Up
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