Application 078457

Type: ANDA
Sponsor: INVAGEN PHARMS

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
A078457-001	QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2007-08-24
A078457-002	QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-08-24
A078457-003	QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-08-24
A078457-004	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	A078457-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2007-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078457-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078457-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078457-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-08-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078457-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2007-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078457-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078457-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078457-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-08-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078457-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2007-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078457-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078457-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078457-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-08-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078457-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2007-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078457-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078457-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078457-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-08-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078457-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2007-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078457-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078457-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078457-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-08-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078457-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2007-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078457-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078457-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078457-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-08-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078457-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2007-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078457-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078457-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078457-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-08-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078457-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2007-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078457-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078457-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078457-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-08-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078457-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2007-08-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078457-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-08-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078457-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-08-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078457-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-08-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078457-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2007-08-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078457-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-08-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078457-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-08-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078457-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-08-24	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 104 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	A078457-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078457-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078457-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078457-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078457-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078457-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078457-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078457-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078457-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078457-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078457-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078457-004	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078457-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078457-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078457-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078457-004	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078457-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078457-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078457-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078457-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078457-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078457-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078457-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078457-004	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078457-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078457-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078457-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078457-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078457-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078457-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078457-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078457-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078457-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078457-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078457-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078457-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078457-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078457-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078457-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078457-004	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Quinapril	QUINAPRIL	Cipla USA Inc.	e6d36e1e-8e35-4d06-83dc-45e0456365fd	2023-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078457 application number: ANDA078457 ndc (product): 69097-843 ndc (product): 69097-839 ndc (product): 69097-842 ndc (product): 69097-841
Quinapril	QUINAPRIL	Proficient Rx LP	f33dbbb1-1a4a-42b0-a5c5-3ac905823206	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078457 application number: ANDA078457 ndc (product): 63187-425

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-267	Quinapril	Quinapril	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-268	Quinapril	Quinapril	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-269	Quinapril	Quinapril	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-270	Quinapril	Quinapril	Camber Pharmaceuticals, Inc.	ANDA	Current
50090-0937	Quinapril	Quinapril	A-S Medication Solutions	ANDA	Current
50090-4649	Quinapril	Quinapril	A-S Medication Solutions	ANDA	Current
50090-4649	Quinapril	Quinapril	A-S Medication Solutions	ANDA	Current
55111-621	Quinapril	Quinapril	Dr.Reddy's Laboratories Limited	ANDA	Current
55111-622	Quinapril	Quinapril	Dr.Reddy's Laboratories Limited	ANDA	Current
55111-623	Quinapril	Quinapril	Dr.Reddy's Laboratories Limited	ANDA	Current
55111-624	Quinapril	Quinapril	Dr.Reddy's Laboratories Limited	ANDA	Current
55154-1032	Quinapril	Quinapril	Cardinal Health	ANDA	Current
63187-425	Quinapril	Quinapril	Proficient Rx LP	ANDA	Current
63187-425	Quinapril	Quinapril	Proficient Rx LP	ANDA	Current
69097-839	Quinapril	Quinapril	Cipla USA Inc.	ANDA	Current
69097-839	Quinapril	Quinapril	Cipla USA Inc.	ANDA	Current
69097-839	Quinapril	Quinapril	Cipla USA Inc.	ANDA	Current
69097-841	Quinapril	Quinapril	Cipla USA Inc.	ANDA	Current
69097-841	Quinapril	Quinapril	Cipla USA Inc.	ANDA	Current
69097-841	Quinapril	Quinapril	Cipla USA Inc.	ANDA	Current
69097-842	Quinapril	Quinapril	Cipla USA Inc.	ANDA	Current
69097-842	Quinapril	Quinapril	Cipla USA Inc.	ANDA	Current
69097-842	Quinapril	Quinapril	Cipla USA Inc.	ANDA	Current
69097-843	Quinapril	Quinapril	Cipla USA Inc.	ANDA	Current
69097-843	Quinapril	Quinapril	Cipla USA Inc.	ANDA	Current
69097-843	Quinapril	Quinapril	Cipla USA Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
23908	ORIG	2007-09-24