Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205823
Company: PRINSTON INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription AB No No
QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription AB No No
QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription AB No No
QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE EQ 40MG BASE TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/15/2016 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/01/2019 SUPPL-2 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

QUINAPRIL HYDROCHLORIDE

TABLET;ORAL; EQ 5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACCUPRIL QUINAPRIL HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription Yes AB 019885 PFIZER PHARMS
QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription No AB 202725 AUROBINDO PHARMA LTD
QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription No AB 078457 INVAGEN PHARMS
QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription No AB 077690 LUPIN
QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription No AB 205823 PRINSTON INC

TABLET;ORAL; EQ 10MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACCUPRIL QUINAPRIL HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription Yes AB 019885 PFIZER PHARMS
QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 202725 AUROBINDO PHARMA LTD
QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 078457 INVAGEN PHARMS
QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 077690 LUPIN
QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 205823 PRINSTON INC

TABLET;ORAL; EQ 20MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACCUPRIL QUINAPRIL HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription Yes AB 019885 PFIZER PHARMS
QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 202725 AUROBINDO PHARMA LTD
QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 078457 INVAGEN PHARMS
QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 077690 LUPIN
QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 205823 PRINSTON INC

TABLET;ORAL; EQ 40MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACCUPRIL QUINAPRIL HYDROCHLORIDE EQ 40MG BASE TABLET;ORAL Prescription Yes AB 019885 PFIZER PHARMS
QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE EQ 40MG BASE TABLET;ORAL Prescription No AB 202725 AUROBINDO PHARMA LTD
QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE EQ 40MG BASE TABLET;ORAL Prescription No AB 078457 INVAGEN PHARMS
QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE EQ 40MG BASE TABLET;ORAL Prescription No AB 077690 LUPIN
QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE EQ 40MG BASE TABLET;ORAL Prescription No AB 205823 PRINSTON INC

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