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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020125-001ACCURETICHYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28
N020125-002ACCURETICHYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28
N020125-003ACCURETICHYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020125-002ACCURETIC12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020125-003ACCURETIC25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020125-001ACCURETIC12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020125-002ACCURETIC12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020125-003ACCURETIC25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020125-001ACCURETIC12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020125-002ACCURETIC12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020125-003ACCURETIC25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020125-001ACCURETIC12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020125-002ACCURETIC12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020125-003ACCURETIC25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020125-001ACCURETIC12.5MG;EQ 10MG BASETABLET / ORALABRLD1999-12-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020125-002ACCURETIC12.5MG;EQ 20MG BASETABLET / ORALABRLD1999-12-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020125-003ACCURETIC25MG;EQ 20MG BASETABLET / ORALABRLD, RS1999-12-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020125-001ACCURETIC12.5MG;EQ 10MG BASETABLET / ORALABRLD1999-12-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020125-002ACCURETIC12.5MG;EQ 20MG BASETABLET / ORALABRLD1999-12-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020125-003ACCURETIC25MG;EQ 20MG BASETABLET / ORALABRLD, RS1999-12-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020125-001ACCURETIC12.5MG;EQ 10MG BASETABLET / ORALABRLD1999-12-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020125-002ACCURETIC12.5MG;EQ 20MG BASETABLET / ORALABRLD1999-12-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020125-003ACCURETIC25MG;EQ 20MG BASETABLET / ORALABRLD, RS1999-12-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020125-001ACCURETIC12.5MG;EQ 10MG BASETABLET / ORALABRLD1999-12-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020125-002ACCURETIC12.5MG;EQ 20MG BASETABLET / ORALABRLD1999-12-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020125-003ACCURETIC25MG;EQ 20MG BASETABLET / ORALABRLD, RS1999-12-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020125-001ACCURETIC12.5MG;EQ 10MG BASETABLET / ORALABRLD1999-12-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N020125-002ACCURETIC12.5MG;EQ 20MG BASETABLET / ORALABRLD1999-12-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N020125-003ACCURETIC25MG;EQ 20MG BASETABLET / ORALABRLD, RS1999-12-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020125-001ACCURETIC12.5MG;EQ 10MG BASETABLET / ORALABRLD1999-12-28782e0a99824c…
2021-12-28 21:50 UTC2021-12N020125-002ACCURETIC12.5MG;EQ 20MG BASETABLET / ORALABRLD1999-12-28782e0a99824c…
2021-12-28 21:50 UTC2021-12N020125-003ACCURETIC25MG;EQ 20MG BASETABLET / ORALABRLD, RS1999-12-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020125-001ACCURETIC12.5MG;EQ 10MG BASETABLET / ORALABRLD1999-12-2887673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020125-002ACCURETIC12.5MG;EQ 20MG BASETABLET / ORALABRLD1999-12-2887673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020125-003ACCURETIC25MG;EQ 20MG BASETABLET / ORALABRLD, RS1999-12-2887673890dc5c…
2021-03-12 10:30 UTC2021-03N020125-001ACCURETIC12.5MG;EQ 10MG BASETABLET / ORALABRLD1999-12-285aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N020125-002ACCURETIC12.5MG;EQ 20MG BASETABLET / ORALABRLD1999-12-285aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N020125-003ACCURETIC25MG;EQ 20MG BASETABLET / ORALABRLD, RS1999-12-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020125-001ACCURETIC12.5MG;EQ 10MG BASETABLET / ORALABRLD1999-12-288869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020125-002ACCURETIC12.5MG;EQ 20MG BASETABLET / ORALABRLD1999-12-288869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020125-003ACCURETIC25MG;EQ 20MG BASETABLET / ORALABRLD, RS1999-12-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020125-001ACCURETIC12.5MG;EQ 10MG BASETABLET / ORALABRLD1999-12-28c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020125-002ACCURETIC12.5MG;EQ 20MG BASETABLET / ORALABRLD1999-12-28c0c555d07b60…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 51 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020125-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020125-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020125-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020125-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020125-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020125-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020125-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020125-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020125-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020125-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020125-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020125-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020125-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N020125-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N020125-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020125-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N020125-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N020125-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020125-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020125-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020125-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N020125-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N020125-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N020125-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020125-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020125-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020125-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020125-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020125-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020125-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020125-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12N020125-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12N020125-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N020125-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09N020125-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09N020125-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N020125-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N020125-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N020125-003AB1ea99ee380514…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020125-001AB13a93d1ddd44b…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 41 matching rows.

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