Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019885
Company: PFIZER PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACCUPRIL QUINAPRIL HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription AB Yes No
ACCUPRIL QUINAPRIL HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription AB Yes No
ACCUPRIL QUINAPRIL HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription AB Yes No
ACCUPRIL QUINAPRIL HYDROCHLORIDE EQ 40MG 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
11/19/1991 ORIG-1 Approval Type 1 - New Molecular Entity 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
04/26/2017 SUPPL-43 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019885s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019885Orig1s043ltr.pdf
02/13/2017 SUPPL-42 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019885s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019885Orig1s042ltr.pdf
09/11/2015 SUPPL-41 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019885s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019885Orig1s041ltr.pdf
05/02/2014 SUPPL-40 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019885s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019885Orig1s040ltr.pdf
10/25/2013 SUPPL-39 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019885s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019885Orig1s039ltr.pdf
09/23/2013 SUPPL-38 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019885s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019885Orig1s038ltr.pdf
04/09/2013 SUPPL-37 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019885s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019885Orig1s037ltr.pdf
09/21/2012 SUPPL-36 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019885s036lbl.pdf
01/18/2012 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019885s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019885s035,020125s012ltr.pdf
10/14/2011 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019885s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019885s033ltr.pdf
09/18/2009 SUPPL-28 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019885s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019885s028ltr.pdf
10/29/2003 SUPPL-23 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19885slr023,20125slr003ltr.pdf
12/13/2002 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

06/21/2001 SUPPL-20 Labeling

Label is not available on this site.

07/22/2002 SUPPL-19 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19885slr019ltr.pdf
04/17/2001 SUPPL-18 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19885S18ltr.pdf
09/10/1999 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

05/04/1998 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

02/25/1998 SUPPL-15 Labeling

Label is not available on this site.

07/03/1997 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

07/02/1997 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/01/1997 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

07/03/1996 SUPPL-11 Labeling

Label is not available on this site.

06/18/1996 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

11/02/1995 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

11/01/1995 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

11/20/1995 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/12/1996 SUPPL-6 Labeling

Label is not available on this site.

05/26/1993 SUPPL-4 Labeling

Label is not available on this site.

10/12/1994 SUPPL-3 Labeling

Label is not available on this site.

05/07/1992 SUPPL-2 Labeling

Label is not available on this site.

10/29/1993 SUPPL-1 Efficacy-New Indication

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-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019885s043lbl.pdf
02/13/2017 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019885s042lbl.pdf
09/11/2015 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019885s041lbl.pdf
05/02/2014 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019885s040lbl.pdf
10/25/2013 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019885s039lbl.pdf
09/23/2013 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019885s038lbl.pdf
04/09/2013 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019885s037lbl.pdf
09/21/2012 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019885s036lbl.pdf
01/18/2012 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019885s035lbl.pdf
10/14/2011 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019885s033lbl.pdf
09/18/2009 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019885s028lbl.pdf

ACCUPRIL

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 076694 MYLAN
QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription No AB 205823 PRINSTON INC
QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription No AB 076607 SUN PHARM INDS LTD
QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription No AB 075504 TEVA

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 076694 MYLAN
QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 205823 PRINSTON INC
QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 076607 SUN PHARM INDS LTD
QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 075504 TEVA

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 076694 MYLAN
QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 205823 PRINSTON INC
QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 076607 SUN PHARM INDS LTD
QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 075504 TEVA

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 076694 MYLAN
QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE EQ 40MG BASE TABLET;ORAL Prescription No AB 205823 PRINSTON INC
QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE EQ 40MG BASE TABLET;ORAL Prescription No AB 076607 SUN PHARM INDS LTD
QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE EQ 40MG BASE TABLET;ORAL Prescription No AB 075504 TEVA

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