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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 two suppliers. Additional details are available on the ACCURETIC profile page.

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

Summary for NDA: 020125

Tradename:
ACCURETIC
Applicant:
Pfizer Pharms
Ingredient:
hydrochlorothiazide; quinapril hydrochloride
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 020125

Ingredient-typeThiazides
Mechanism of ActionAngiotensin-converting Enzyme Inhibitors
Physiological EffectIncreased 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 0071-0220 0071-0220-23 90 TABLET, FILM COATED in 1 BOTTLE (0071-0220-23)
ACCURETIC
hydrochlorothiazide; quinapril hydrochloride
TABLET;ORAL 020125 NDA Parke-Davis Div of Pfizer Inc 0071-0222 0071-0222-23 90 TABLET, FILM COATED in 1 BOTTLE (0071-0222-23)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;EQ 10MG BASE
Approval Date:Dec 28, 1999TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;EQ 20MG BASE
Approval Date:Dec 28, 1999TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;EQ 20MG BASE
Approval Date:Dec 28, 1999TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 020125

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer Pharms
ACCURETIC
hydrochlorothiazide; quinapril hydrochloride
TABLET;ORAL020125-001Dec 28, 19994,344,949*PED► subscribe
Pfizer Pharms
ACCURETIC
hydrochlorothiazide; quinapril hydrochloride
TABLET;ORAL020125-003Dec 28, 19994,344,949*PED► subscribe
Pfizer Pharms
ACCURETIC
hydrochlorothiazide; quinapril hydrochloride
TABLET;ORAL020125-002Dec 28, 19994,743,450*PED► subscribe
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