Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091524
Company: APOTEX CORP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 12.5MG;EQ 10MG BASE TABLET;ORAL Prescription AB No No
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 12.5MG;EQ 20MG BASE TABLET;ORAL Prescription AB No No
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 25MG;EQ 20MG 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
03/12/2013 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/16/2016 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

11/26/2014 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

11/26/2014 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

11/26/2014 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

TABLET;ORAL; 12.5MG;EQ 10MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACCURETIC HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 12.5MG;EQ 10MG BASE TABLET;ORAL Prescription Yes AB 020125 PFIZER PHARMS
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 12.5MG;EQ 10MG BASE TABLET;ORAL Prescription No AB 091524 APOTEX CORP
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 12.5MG;EQ 10MG BASE TABLET;ORAL Prescription No AB 078450 AUROBINDO PHARMA
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 12.5MG;EQ 10MG BASE TABLET;ORAL Prescription No AB 201356 INVAGEN PHARMS
QUINARETIC HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 12.5MG;EQ 10MG BASE TABLET;ORAL Prescription No AB 076374 LUPIN

TABLET;ORAL; 12.5MG;EQ 20MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACCURETIC HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 12.5MG;EQ 20MG BASE TABLET;ORAL Prescription Yes AB 020125 PFIZER PHARMS
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 12.5MG;EQ 20MG BASE TABLET;ORAL Prescription No AB 091524 APOTEX CORP
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 12.5MG;EQ 20MG BASE TABLET;ORAL Prescription No AB 078450 AUROBINDO PHARMA
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 12.5MG;EQ 20MG BASE TABLET;ORAL Prescription No AB 201356 INVAGEN PHARMS
QUINARETIC HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 12.5MG;EQ 20MG BASE TABLET;ORAL Prescription No AB 076374 LUPIN

TABLET;ORAL; 25MG;EQ 20MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACCURETIC HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 25MG;EQ 20MG BASE TABLET;ORAL Prescription Yes AB 020125 PFIZER PHARMS
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 25MG;EQ 20MG BASE TABLET;ORAL Prescription No AB 091524 APOTEX CORP
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 25MG;EQ 20MG BASE TABLET;ORAL Prescription No AB 078450 AUROBINDO PHARMA
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 25MG;EQ 20MG BASE TABLET;ORAL Prescription No AB 201356 INVAGEN PHARMS
QUINARETIC HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 25MG;EQ 20MG BASE TABLET;ORAL Prescription No AB 076374 LUPIN

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