Application 019885

Type: NDA
Sponsor: PFIZER PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACCUPRIL	QUINAPRIL HYDROCHLORIDE	TABLET;ORAL	EQ 5MG BASE	Yes	No
002	ACCUPRIL	QUINAPRIL HYDROCHLORIDE	TABLET;ORAL	EQ 10MG BASE	Yes	No
003	ACCUPRIL	QUINAPRIL HYDROCHLORIDE	TABLET;ORAL	EQ 20MG BASE	Yes	No
004	ACCUPRIL	QUINAPRIL HYDROCHLORIDE	TABLET;ORAL	EQ 40MG BASE	Yes	Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N019885-001	ACCUPRIL	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19
N019885-002	ACCUPRIL	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19
N019885-003	ACCUPRIL	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19
N019885-004	ACCUPRIL	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19

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 4 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019885-001	ACCUPRIL	EQ 5MG BASE	TABLET / ORAL		RLD	1991-11-19	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019885-002	ACCUPRIL	EQ 10MG BASE	TABLET / ORAL		RLD	1991-11-19	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019885-003	ACCUPRIL	EQ 20MG BASE	TABLET / ORAL		RLD	1991-11-19	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019885-004	ACCUPRIL	EQ 40MG BASE	TABLET / ORAL		RLD	1991-11-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019885-001	ACCUPRIL	EQ 5MG BASE	TABLET / ORAL		RLD	1991-11-19	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N019885-002	ACCUPRIL	EQ 10MG BASE	TABLET / ORAL		RLD	1991-11-19	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N019885-003	ACCUPRIL	EQ 20MG BASE	TABLET / ORAL		RLD	1991-11-19	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N019885-004	ACCUPRIL	EQ 40MG BASE	TABLET / ORAL		RLD	1991-11-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019885-001	ACCUPRIL	EQ 5MG BASE	TABLET / ORAL		RLD	1991-11-19	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N019885-002	ACCUPRIL	EQ 10MG BASE	TABLET / ORAL		RLD	1991-11-19	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N019885-003	ACCUPRIL	EQ 20MG BASE	TABLET / ORAL		RLD	1991-11-19	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N019885-004	ACCUPRIL	EQ 40MG BASE	TABLET / ORAL		RLD	1991-11-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019885-001	ACCUPRIL	EQ 5MG BASE	TABLET / ORAL		RLD	1991-11-19	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019885-002	ACCUPRIL	EQ 10MG BASE	TABLET / ORAL		RLD	1991-11-19	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019885-003	ACCUPRIL	EQ 20MG BASE	TABLET / ORAL		RLD	1991-11-19	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019885-004	ACCUPRIL	EQ 40MG BASE	TABLET / ORAL		RLD	1991-11-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019885-001	ACCUPRIL	EQ 5MG BASE	TABLET / ORAL		RLD	1991-11-19	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019885-002	ACCUPRIL	EQ 10MG BASE	TABLET / ORAL		RLD	1991-11-19	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019885-003	ACCUPRIL	EQ 20MG BASE	TABLET / ORAL		RLD	1991-11-19	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019885-004	ACCUPRIL	EQ 40MG BASE	TABLET / ORAL		RLD	1991-11-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019885-001	ACCUPRIL	EQ 5MG BASE	TABLET / ORAL		RLD	1991-11-19	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019885-002	ACCUPRIL	EQ 10MG BASE	TABLET / ORAL		RLD	1991-11-19	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019885-003	ACCUPRIL	EQ 20MG BASE	TABLET / ORAL		RLD	1991-11-19	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019885-004	ACCUPRIL	EQ 40MG BASE	TABLET / ORAL		RLD	1991-11-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019885-001	ACCUPRIL	EQ 5MG BASE	TABLET / ORAL		RLD	1991-11-19	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019885-002	ACCUPRIL	EQ 10MG BASE	TABLET / ORAL		RLD	1991-11-19	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019885-003	ACCUPRIL	EQ 20MG BASE	TABLET / ORAL		RLD	1991-11-19	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019885-004	ACCUPRIL	EQ 40MG BASE	TABLET / ORAL		RLD	1991-11-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019885-001	ACCUPRIL	EQ 5MG BASE	TABLET / ORAL		RLD	1991-11-19	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N019885-002	ACCUPRIL	EQ 10MG BASE	TABLET / ORAL		RLD	1991-11-19	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N019885-003	ACCUPRIL	EQ 20MG BASE	TABLET / ORAL		RLD	1991-11-19	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N019885-004	ACCUPRIL	EQ 40MG BASE	TABLET / ORAL		RLD	1991-11-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019885-001	ACCUPRIL	EQ 5MG BASE	TABLET / ORAL		RLD	1991-11-19	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N019885-002	ACCUPRIL	EQ 10MG BASE	TABLET / ORAL		RLD	1991-11-19	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N019885-003	ACCUPRIL	EQ 20MG BASE	TABLET / ORAL		RLD	1991-11-19	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N019885-004	ACCUPRIL	EQ 40MG BASE	TABLET / ORAL		RLD	1991-11-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019885-001	ACCUPRIL	EQ 5MG BASE	TABLET / ORAL	AB	RLD	1991-11-19	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019885-002	ACCUPRIL	EQ 10MG BASE	TABLET / ORAL	AB	RLD	1991-11-19	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019885-003	ACCUPRIL	EQ 20MG BASE	TABLET / ORAL	AB	RLD	1991-11-19	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019885-004	ACCUPRIL	EQ 40MG BASE	TABLET / ORAL	AB	RLD, RS	1991-11-19	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019885-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019885-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019885-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019885-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019885-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019885-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019885-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019885-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019885-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019885-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019885-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019885-004	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019885-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019885-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019885-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019885-004	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019885-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019885-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019885-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019885-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019885-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019885-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019885-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019885-004	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019885-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019885-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019885-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019885-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019885-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019885-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019885-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019885-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019885-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019885-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019885-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019885-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019885-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019885-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019885-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019885-004	AB	1	`c0c555d07b60…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Quinapril	QUINAPRIL HYDROCHLORIDE	Bryant Ranch Prepack	a62d0ed3-8fcc-45fb-9246-b57b08a11f60	2024-05-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: QUINAPRIL HYDROCHLORIDE
Quinapril	QUINAPRIL HYDROCHLORIDE	Aurobindo Pharma Limited	93e6e668-5306-4f26-81d8-cbc3a7a5e787	2024-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: QUINAPRIL HYDROCHLORIDE
Quinapril	QUINAPRIL HYDROCHLORIDE	Proficient Rx LP	42e4f9dd-6032-4257-bd0f-8e9b71027f03	2020-03-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: QUINAPRIL HYDROCHLORIDE

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 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0071-0527	Accupril	quinapril hydrochloride	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0527	Accupril	quinapril hydrochloride	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0527	Accupril	quinapril hydrochloride	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0527	Accupril	quinapril hydrochloride	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0527	Accupril	quinapril hydrochloride	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0527	Accupril	quinapril hydrochloride	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0527	Accupril	quinapril hydrochloride	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0530	Accupril	quinapril hydrochloride	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0530	Accupril	quinapril hydrochloride	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0530	Accupril	quinapril hydrochloride	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0530	Accupril	quinapril hydrochloride	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0530	Accupril	quinapril hydrochloride	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0530	Accupril	quinapril hydrochloride	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0530	Accupril	quinapril hydrochloride	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0532	Accupril	quinapril hydrochloride	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0532	Accupril	quinapril hydrochloride	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0532	Accupril	quinapril hydrochloride	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0532	Accupril	quinapril hydrochloride	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0532	Accupril	quinapril hydrochloride	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0532	Accupril	quinapril hydrochloride	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0532	Accupril	quinapril hydrochloride	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0535	Accupril	quinapril hydrochloride	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0535	Accupril	quinapril hydrochloride	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0535	Accupril	quinapril hydrochloride	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0535	Accupril	quinapril hydrochloride	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0535	Accupril	quinapril hydrochloride	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0535	Accupril	quinapril hydrochloride	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0535	Accupril	quinapril hydrochloride	Parke-Davis Div of Pfizer Inc	NDA	Current
68151-1020	Quinapril Hydrochloride	quinapril hydrochloride	Carilion Materials Management	NDA AUTHORIZED GENERIC	Current
68151-1021	Quinapril Hydrochloride	quinapril hydrochloride	Carilion Materials Management	NDA AUTHORIZED GENERIC	Current
68151-1022	Quinapril Hydrochloride	quinapril hydrochloride	Carilion Materials Management	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83827	SUPPL	2025-10-20
63153	SUPPL	2020-05-20
48212	SUPPL	2017-05-02
48134	SUPPL	2017-04-27
47216	SUPPL	2017-02-15
47194	SUPPL	2017-02-14
11812	SUPPL	2015-09-14
1760	SUPPL	2015-09-14
34065	SUPPL	2014-05-06
19791	SUPPL	2014-05-06
11811	SUPPL	2013-10-31
1759	SUPPL	2013-10-28
1758	SUPPL	2013-09-24
11810	SUPPL	2013-09-23
34064	SUPPL	2013-04-16
1757	SUPPL	2013-04-11
11809	SUPPL	2012-09-25
34063	SUPPL	2012-01-23
1756	SUPPL	2012-01-23
11808	SUPPL	2011-10-20
1755	SUPPL	2011-10-18
1754	SUPPL	2009-11-12
11807	SUPPL	2009-10-01
44038	ORIG	2006-06-09
1753	SUPPL	2003-11-05
19790	SUPPL	2003-07-30
1752	SUPPL	2001-04-17