Application 075504

Type: ANDA
Sponsor: ANI PHARMS INC

Application Products#

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

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-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A075504-001	QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2007-08-24
A075504-002	QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-08-24
A075504-003	QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-08-24
A075504-004	QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-08-24

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075504-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2007-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075504-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075504-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075504-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-08-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075504-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2007-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075504-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075504-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075504-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-08-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075504-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2007-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075504-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075504-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075504-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-08-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075504-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2007-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075504-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075504-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075504-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-08-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075504-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2007-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075504-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075504-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075504-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-08-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075504-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2007-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075504-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075504-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075504-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-08-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075504-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2007-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075504-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075504-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075504-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-08-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075504-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2007-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075504-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075504-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075504-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-08-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075504-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2007-08-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075504-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-08-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075504-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-08-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075504-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-08-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075504-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2007-08-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075504-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-08-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075504-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-08-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075504-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-08-24	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A075504-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075504-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075504-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075504-004	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A075504-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075504-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075504-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075504-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075504-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075504-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075504-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075504-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075504-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075504-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075504-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075504-004	AB	1	`ea99ee380514…`

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

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63629-1241	Quinapril	Quinapril	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44260	ORIG	2007-09-24
8698	ORIG	2003-04-10