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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019885-001ACCUPRILQUINAPRIL HYDROCHLORIDEEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-11-19
N019885-002ACCUPRILQUINAPRIL HYDROCHLORIDEEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-11-19
N019885-003ACCUPRILQUINAPRIL HYDROCHLORIDEEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-11-19
N019885-004ACCUPRILQUINAPRIL HYDROCHLORIDEEQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-11-19

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 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N019885-001ACCUPRILEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-11-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019885-002ACCUPRILEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-11-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019885-003ACCUPRILEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-11-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019885-004ACCUPRILEQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-11-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019885-001ACCUPRILEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-11-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019885-002ACCUPRILEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-11-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019885-003ACCUPRILEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-11-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019885-004ACCUPRILEQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-11-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08N019885-001ACCUPRILEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-11-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019885-002ACCUPRILEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-11-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019885-003ACCUPRILEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-11-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019885-004ACCUPRILEQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-11-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019885-001ACCUPRILEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-11-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019885-002ACCUPRILEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-11-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019885-003ACCUPRILEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-11-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019885-004ACCUPRILEQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-11-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019885-001ACCUPRILEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-11-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019885-002ACCUPRILEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-11-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019885-003ACCUPRILEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-11-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019885-004ACCUPRILEQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-11-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019885-001ACCUPRILEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-11-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019885-002ACCUPRILEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-11-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019885-003ACCUPRILEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-11-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019885-004ACCUPRILEQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-11-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019885-001ACCUPRILEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-11-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019885-002ACCUPRILEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-11-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019885-003ACCUPRILEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-11-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019885-004ACCUPRILEQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-11-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019885-001ACCUPRILEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-11-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019885-002ACCUPRILEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-11-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019885-003ACCUPRILEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-11-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019885-004ACCUPRILEQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-11-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019885-001ACCUPRILEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-11-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019885-002ACCUPRILEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-11-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019885-003ACCUPRILEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-11-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019885-004ACCUPRILEQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-11-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019885-001ACCUPRILEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-11-19d06236e962d9…
2024-10-29 15:01 UTC2024-10N019885-002ACCUPRILEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-11-19d06236e962d9…
2024-10-29 15:01 UTC2024-10N019885-003ACCUPRILEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-11-19d06236e962d9…
2024-10-29 15:01 UTC2024-10N019885-004ACCUPRILEQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1991-11-19d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019885-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019885-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019885-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019885-004AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019885-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N019885-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N019885-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N019885-004AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019885-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N019885-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N019885-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N019885-004AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019885-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019885-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019885-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019885-004AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019885-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N019885-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N019885-003AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N019885-004AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019885-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N019885-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N019885-003AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N019885-004AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019885-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019885-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019885-003AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019885-004AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N019885-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N019885-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N019885-003AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N019885-004AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019885-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N019885-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N019885-003AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N019885-004AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019885-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N019885-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N019885-003AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N019885-004AB1c0c555d07b60…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
QuinaprilQUINAPRIL HYDROCHLORIDEBryant Ranch Prepacka62d0ed3-8fcc-45fb-9246-b57b08a11f602024-05-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUINAPRIL HYDROCHLORIDE
QuinaprilQUINAPRIL HYDROCHLORIDEAurobindo Pharma Limited93e6e668-5306-4f26-81d8-cbc3a7a5e7872024-05-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUINAPRIL HYDROCHLORIDE
QuinaprilQUINAPRIL HYDROCHLORIDEProficient Rx LP42e4f9dd-6032-4257-bd0f-8e9b71027f032020-03-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUINAPRIL HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

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