FDA.reportPublic FDA data

Application 019885

Type
NDA
Sponsor
PFIZER PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACCUPRILQUINAPRIL HYDROCHLORIDETABLET;ORALEQ 5MG BASEYesNo
002ACCUPRILQUINAPRIL HYDROCHLORIDETABLET;ORALEQ 10MG BASEYesNo
003ACCUPRILQUINAPRIL HYDROCHLORIDETABLET;ORALEQ 20MG BASEYesNo
004ACCUPRILQUINAPRIL HYDROCHLORIDETABLET;ORALEQ 40MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0071-0527Accuprilquinapril hydrochlorideParke-Davis Div of Pfizer IncNDACurrent
0071-0527Accuprilquinapril hydrochlorideParke-Davis Div of Pfizer IncNDACurrent
0071-0527Accuprilquinapril hydrochlorideParke-Davis Div of Pfizer IncNDACurrent
0071-0527Accuprilquinapril hydrochlorideParke-Davis Div of Pfizer IncNDACurrent
0071-0527Accuprilquinapril hydrochlorideParke-Davis Div of Pfizer IncNDACurrent
0071-0527Accuprilquinapril hydrochlorideParke-Davis Div of Pfizer IncNDACurrent
0071-0527Accuprilquinapril hydrochlorideParke-Davis Div of Pfizer IncNDACurrent
0071-0530Accuprilquinapril hydrochlorideParke-Davis Div of Pfizer IncNDACurrent
0071-0530Accuprilquinapril hydrochlorideParke-Davis Div of Pfizer IncNDACurrent
0071-0530Accuprilquinapril hydrochlorideParke-Davis Div of Pfizer IncNDACurrent
0071-0530Accuprilquinapril hydrochlorideParke-Davis Div of Pfizer IncNDACurrent
0071-0530Accuprilquinapril hydrochlorideParke-Davis Div of Pfizer IncNDACurrent
0071-0530Accuprilquinapril hydrochlorideParke-Davis Div of Pfizer IncNDACurrent
0071-0530Accuprilquinapril hydrochlorideParke-Davis Div of Pfizer IncNDACurrent
0071-0532Accuprilquinapril hydrochlorideParke-Davis Div of Pfizer IncNDACurrent
0071-0532Accuprilquinapril hydrochlorideParke-Davis Div of Pfizer IncNDACurrent
0071-0532Accuprilquinapril hydrochlorideParke-Davis Div of Pfizer IncNDACurrent
0071-0532Accuprilquinapril hydrochlorideParke-Davis Div of Pfizer IncNDACurrent
0071-0532Accuprilquinapril hydrochlorideParke-Davis Div of Pfizer IncNDACurrent
0071-0532Accuprilquinapril hydrochlorideParke-Davis Div of Pfizer IncNDACurrent
0071-0532Accuprilquinapril hydrochlorideParke-Davis Div of Pfizer IncNDACurrent
0071-0535Accuprilquinapril hydrochlorideParke-Davis Div of Pfizer IncNDACurrent
0071-0535Accuprilquinapril hydrochlorideParke-Davis Div of Pfizer IncNDACurrent
0071-0535Accuprilquinapril hydrochlorideParke-Davis Div of Pfizer IncNDACurrent
0071-0535Accuprilquinapril hydrochlorideParke-Davis Div of Pfizer IncNDACurrent
0071-0535Accuprilquinapril hydrochlorideParke-Davis Div of Pfizer IncNDACurrent
0071-0535Accuprilquinapril hydrochlorideParke-Davis Div of Pfizer IncNDACurrent
0071-0535Accuprilquinapril hydrochlorideParke-Davis Div of Pfizer IncNDACurrent
68151-1020Quinapril Hydrochloridequinapril hydrochlorideCarilion Materials ManagementNDA AUTHORIZED GENERICCurrent
68151-1021Quinapril Hydrochloridequinapril hydrochlorideCarilion Materials ManagementNDA AUTHORIZED GENERICCurrent
68151-1022Quinapril Hydrochloridequinapril hydrochlorideCarilion Materials ManagementNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83827SUPPL 2025-10-20
63153SUPPL2020-05-20
48212SUPPL2017-05-02
48134SUPPL2017-04-27
47216SUPPL2017-02-15
47194SUPPL2017-02-14
11812SUPPL2015-09-14
1760SUPPL2015-09-14
34065SUPPL2014-05-06
19791SUPPL2014-05-06
11811SUPPL2013-10-31
1759SUPPL2013-10-28
1758SUPPL2013-09-24
11810SUPPL2013-09-23
34064SUPPL2013-04-16
1757SUPPL2013-04-11
11809SUPPL2012-09-25
34063SUPPL2012-01-23
1756SUPPL2012-01-23
11808SUPPL2011-10-20
1755SUPPL2011-10-18
1754SUPPL2009-11-12
11807SUPPL2009-10-01
44038ORIG2006-06-09
1753SUPPL2003-11-05
19790SUPPL2003-07-30
1752SUPPL2001-04-17