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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 six suppliers. 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. Twenty suppliers are listed for this compound. Additional details are available on the quinapril hydrochloride profile page.

Summary for NDA: 019885

Tradename:
ACCUPRIL
Applicant:
Pfizer Pharms
Ingredient:
quinapril hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Nov 19, 1991TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Nov 19, 1991TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Nov 19, 1991TE:ABRLD:No

Expired Orange Book Patents for NDA: 019885

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer Pharms
ACCUPRIL
quinapril hydrochloride
TABLET;ORAL019885-003Nov 19, 19915,684,016*PED► subscribe
Pfizer Pharms
ACCUPRIL
quinapril hydrochloride
TABLET;ORAL019885-004Nov 19, 19915,684,016*PED► subscribe
Pfizer Pharms
ACCUPRIL
quinapril hydrochloride
TABLET;ORAL019885-001Nov 19, 19914,344,949*PED► subscribe
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