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Last Updated: October 24, 2019

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Details for New Drug Application (NDA): 019885

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NDA 019885 describes ACCUPRIL, 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 ACCUPRIL profile page.

The generic ingredient in ACCUPRIL is quinapril hydrochloride. There are eleven drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the quinapril hydrochloride profile page.
Summary for 019885
Tradename:ACCUPRIL
Applicant:Pfizer Pharms
Ingredient:quinapril hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 019885
Suppliers and Packaging for NDA: 019885
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACCUPRIL quinapril hydrochloride TABLET;ORAL 019885 NDA Parke-Davis Div of Pfizer Inc 0071-0527 0071-0527-23 90 TABLET, FILM COATED in 1 BOTTLE (0071-0527-23)
ACCUPRIL quinapril hydrochloride TABLET;ORAL 019885 NDA Parke-Davis Div of Pfizer Inc 0071-0527 0071-0527-40 100 BLISTER PACK in 1 CARTON (0071-0527-40) > 1 TABLET, FILM COATED in 1 BLISTER PACK
Paragraph IV (Patent) Challenges for 019885
Tradename Dosage Ingredient NDA Submissiondate
ACCUPRIL TABLET;ORAL quinapril hydrochloride 019885

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Nov 19, 1991TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Nov 19, 1991TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Nov 19, 1991TE:ABRLD:Yes

Expired US Patents for NDA 019885

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer Pharms ACCUPRIL quinapril hydrochloride TABLET;ORAL 019885-001 Nov 19, 1991   Start Trial   Start Trial
Pfizer Pharms ACCUPRIL quinapril hydrochloride TABLET;ORAL 019885-003 Nov 19, 1991   Start Trial   Start Trial
Pfizer Pharms ACCUPRIL quinapril hydrochloride TABLET;ORAL 019885-004 Nov 19, 1991   Start Trial   Start Trial
Pfizer Pharms ACCUPRIL quinapril hydrochloride TABLET;ORAL 019885-004 Nov 19, 1991   Start Trial   Start Trial
Pfizer Pharms ACCUPRIL quinapril hydrochloride TABLET;ORAL 019885-002 Nov 19, 1991   Start Trial   Start Trial
Pfizer Pharms ACCUPRIL quinapril hydrochloride TABLET;ORAL 019885-004 Nov 19, 1991   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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