Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020125
Company: PFIZER PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACCURETIC HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 12.5MG;EQ 10MG BASE TABLET;ORAL Prescription AB Yes No
ACCURETIC HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 12.5MG;EQ 20MG BASE TABLET;ORAL Prescription AB Yes No
ACCURETIC HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 25MG;EQ 20MG BASE TABLET;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/28/1999 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20125lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20125ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20125_Accuretic.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/26/2017 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020125s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020125Orig1s022ltr.pdf
06/06/2016 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

09/11/2015 SUPPL-20 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020125s020lbl.pdf
02/05/2015 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020125s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020125Orig1s019ltr.pdf
05/02/2014 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020125s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020125Orig1s018ltr.pdf
10/25/2013 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020125s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020125Orig1s017ltr.pdf
01/17/2014 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020125s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020125Orig1s016ltr_replacement.pdf
09/23/2013 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020125s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020125Orig1s015ltr.pdf
09/21/2012 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020125s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020125Orig1s014ltr.pdf
12/19/2012 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

01/18/2012 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020125s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019885s035,020125s012ltr.pdf
10/14/2011 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020125s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020125s011ltr.pdf
03/20/2011 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020125s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020125s010ltr.pdf
09/18/2009 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020125s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020125s007ltr.pdf
10/29/2003 SUPPL-3 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19885slr023,20125slr003ltr.pdf
01/28/2002 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/26/2017 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020125s022lbl.pdf
09/11/2015 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020125s020lbl.pdf
02/05/2015 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020125s019lbl.pdf
05/02/2014 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020125s018lbl.pdf
01/17/2014 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020125s016lbl.pdf
10/25/2013 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020125s017lbl.pdf
09/23/2013 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020125s015lbl.pdf
09/21/2012 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020125s014lbl.pdf
01/18/2012 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020125s012lbl.pdf
10/14/2011 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020125s011lbl.pdf
03/20/2011 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020125s010lbl.pdf
09/18/2009 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020125s007lbl.pdf
12/28/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20125lbl.pdf

ACCURETIC

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
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 12.5MG;EQ 10MG BASE TABLET;ORAL Prescription No AB 077093 MYLAN
QUINARETIC HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 12.5MG;EQ 10MG BASE TABLET;ORAL Prescription No AB 076374 GAVIS PHARMS

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
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 12.5MG;EQ 20MG BASE TABLET;ORAL Prescription No AB 077093 MYLAN
QUINARETIC HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 12.5MG;EQ 20MG BASE TABLET;ORAL Prescription No AB 076374 GAVIS PHARMS

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
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 25MG;EQ 20MG BASE TABLET;ORAL Prescription No AB 077093 MYLAN
QUINARETIC HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 25MG;EQ 20MG BASE TABLET;ORAL Prescription No AB 076374 GAVIS PHARMS

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