FDA.reportPublic FDA data

Application 020125

Type
NDA
Sponsor
PFIZER PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACCURETICHYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDETABLET;ORAL12.5MG;EQ 10MG BASEYesNo
002ACCURETICHYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDETABLET;ORAL12.5MG;EQ 20MG BASEYesNo
003ACCURETICHYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDETABLET;ORAL25MG;EQ 20MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0071-0220ACCURETICquinapril hydrochloride and hydrochlorothiazideParke-Davis Div of Pfizer IncNDACurrent
0071-0220ACCURETICquinapril hydrochloride and hydrochlorothiazideParke-Davis Div of Pfizer IncNDACurrent
0071-0220ACCURETICquinapril hydrochloride and hydrochlorothiazideParke-Davis Div of Pfizer IncNDACurrent
0071-0220ACCURETICquinapril hydrochloride and hydrochlorothiazideParke-Davis Div of Pfizer IncNDACurrent
0071-0220ACCURETICquinapril hydrochloride and hydrochlorothiazideParke-Davis Div of Pfizer IncNDACurrent
0071-0220ACCURETICquinapril hydrochloride and hydrochlorothiazideParke-Davis Div of Pfizer IncNDACurrent
0071-0220ACCURETICquinapril hydrochloride and hydrochlorothiazideParke-Davis Div of Pfizer IncNDACurrent
0071-0222ACCURETICquinapril hydrochloride and hydrochlorothiazideParke-Davis Div of Pfizer IncNDACurrent
0071-0222ACCURETICquinapril hydrochloride and hydrochlorothiazideParke-Davis Div of Pfizer IncNDACurrent
0071-0222ACCURETICquinapril hydrochloride and hydrochlorothiazideParke-Davis Div of Pfizer IncNDACurrent
0071-0222ACCURETICquinapril hydrochloride and hydrochlorothiazideParke-Davis Div of Pfizer IncNDACurrent
0071-0222ACCURETICquinapril hydrochloride and hydrochlorothiazideParke-Davis Div of Pfizer IncNDACurrent
0071-0222ACCURETICquinapril hydrochloride and hydrochlorothiazideParke-Davis Div of Pfizer IncNDACurrent
0071-0222ACCURETICquinapril hydrochloride and hydrochlorothiazideParke-Davis Div of Pfizer IncNDACurrent
0071-0223ACCURETICquinapril hydrochloride and hydrochlorothiazideParke-Davis Div of Pfizer IncNDACurrent
0071-0223ACCURETICquinapril hydrochloride and hydrochlorothiazideParke-Davis Div of Pfizer IncNDACurrent
0071-0223ACCURETICquinapril hydrochloride and hydrochlorothiazideParke-Davis Div of Pfizer IncNDACurrent
0071-0223ACCURETICquinapril hydrochloride and hydrochlorothiazideParke-Davis Div of Pfizer IncNDACurrent
0071-0223ACCURETICquinapril hydrochloride and hydrochlorothiazideParke-Davis Div of Pfizer IncNDACurrent
0071-0223ACCURETICquinapril hydrochloride and hydrochlorothiazideParke-Davis Div of Pfizer IncNDACurrent
0071-0223ACCURETICquinapril hydrochloride and hydrochlorothiazideParke-Davis Div of Pfizer IncNDACurrent
0071-3112ACCURETICquinapril and hydrochlorothiazideParke-Davis Div of Pfizer IncNDACurrent
0071-3112ACCURETICquinapril and hydrochlorothiazideParke-Davis Div of Pfizer IncNDACurrent
0071-5212ACCURETICquinapril and hydrochlorothiazideParke-Davis Div of Pfizer IncNDACurrent
0071-5212ACCURETICquinapril and hydrochlorothiazideParke-Davis Div of Pfizer IncNDACurrent
59762-0220quinapril hydrochloride and hydrochlorothiazidequinapril hydrochloride and hydrochlorothiazideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0220quinapril hydrochloride and hydrochlorothiazidequinapril hydrochloride and hydrochlorothiazideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0220quinapril hydrochloride and hydrochlorothiazidequinapril hydrochloride and hydrochlorothiazideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0220quinapril hydrochloride and hydrochlorothiazidequinapril hydrochloride and hydrochlorothiazideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0220quinapril hydrochloride and hydrochlorothiazidequinapril hydrochloride and hydrochlorothiazideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0222quinapril hydrochloride and hydrochlorothiazidequinapril hydrochloride and hydrochlorothiazideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0222quinapril hydrochloride and hydrochlorothiazidequinapril hydrochloride and hydrochlorothiazideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0222quinapril hydrochloride and hydrochlorothiazidequinapril hydrochloride and hydrochlorothiazideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0222quinapril hydrochloride and hydrochlorothiazidequinapril hydrochloride and hydrochlorothiazideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0222quinapril hydrochloride and hydrochlorothiazidequinapril hydrochloride and hydrochlorothiazideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0223quinapril hydrochloride and hydrochlorothiazidequinapril hydrochloride and hydrochlorothiazideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0223quinapril hydrochloride and hydrochlorothiazidequinapril hydrochloride and hydrochlorothiazideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0223quinapril hydrochloride and hydrochlorothiazidequinapril hydrochloride and hydrochlorothiazideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0223quinapril hydrochloride and hydrochlorothiazidequinapril hydrochloride and hydrochlorothiazideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0223quinapril hydrochloride and hydrochlorothiazidequinapril hydrochloride and hydrochlorothiazideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5225quinapril and hydrochlorothiazidequinapril and hydrochlorothiazideGreenstone LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
66322SUPPL2021-02-23
66315SUPPL2021-02-22
64433SUPPL2020-08-27
64353SUPPL2020-08-21
62831SUPPL2020-05-06
62830SUPPL2020-05-06
48205SUPPL2017-05-02
48128SUPPL2017-04-27
12237SUPPL2015-09-14
34286SUPPL2015-02-06
2048SUPPL2015-02-06
21190SUPPL2014-05-06
12236SUPPL2014-05-06
34284SUPPL2014-01-22
2047SUPPL2014-01-21
34285SUPPL2013-10-31
21189SUPPL2013-10-28
21188SUPPL2013-09-24
34283SUPPL2013-09-23
34282SUPPL2012-09-25
2046SUPPL2012-09-24
34281SUPPL2012-01-23
2045SUPPL2012-01-23
34280SUPPL2011-10-20
21187SUPPL2011-10-18
2044SUPPL2011-03-24
12235SUPPL2011-03-22
2043SUPPL2009-11-12
12234SUPPL2009-10-01
2042SUPPL2003-11-05
41148ORIG2001-05-31
34279ORIG1999-12-28
21186ORIG1999-12-28