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 43.

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QUINAPRIL HYDROCHLORIDE12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28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QUINAPRIL HYDROCHLORIDE12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28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QUINAPRIL HYDROCHLORIDE25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28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 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020125-001ACCURETIC12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-2884e616aacf4f…
2026-09-14 22:38:342026-08N020125-002ACCURETIC12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-2884e616aacf4f…
2026-09-14 22:38:342026-08N020125-003ACCURETIC25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-2884e616aacf4f…
2026-08-18 06:07:402026-07N020125-001ACCURETIC12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28caaa826d4ba7…
2026-08-18 06:07:402026-07N020125-002ACCURETIC12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28caaa826d4ba7…
2026-08-18 06:07:402026-07N020125-003ACCURETIC25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020125-001ACCURETIC12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020125-002ACCURETIC12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020125-003ACCURETIC25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020125-001ACCURETIC12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020125-002ACCURETIC12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020125-003ACCURETIC25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N020125-001ACCURETIC12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020125-002ACCURETIC12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020125-003ACCURETIC25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020125-001ACCURETIC12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020125-002ACCURETIC12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020125-003ACCURETIC25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020125-001ACCURETIC12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020125-002ACCURETIC12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020125-003ACCURETIC25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020125-001ACCURETIC12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020125-002ACCURETIC12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020125-003ACCURETIC25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020125-001ACCURETIC12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020125-002ACCURETIC12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020125-003ACCURETIC25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020125-001ACCURETIC12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020125-002ACCURETIC12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020125-003ACCURETIC25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020125-001ACCURETIC12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020125-002ACCURETIC12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020125-003ACCURETIC25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020125-001ACCURETIC12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28d06236e962d9…
2024-10-29 15:01 UTC2024-10N020125-002ACCURETIC12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28d06236e962d9…
2024-10-29 15:01 UTC2024-10N020125-003ACCURETIC25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020125-001ACCURETIC12.5MG;EQ 10MG 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 ZIP2024-08N020125-002ACCURETIC12.5MG;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…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020125-002AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020125-003AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020125-001AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N020125-002AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N020125-003AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020125-001AB1e64feba35796…
2022-09-29 23:25 UTC2022-09N020125-002AB1e64feba35796…
2022-09-29 23:25 UTC2022-09N020125-003AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020125-001AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020125-002AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020125-003AB1cb3db0bc1861…

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