Application 205823

Type: ANDA
Sponsor: PRINSTON 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 42.

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	TE codes	Approval date
A205823-001	QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2016-09-15
A205823-002	QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-09-15
A205823-003	QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-09-15
A205823-004	QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2016-09-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A205823-001	AB
A205823-002	AB
A205823-003	AB
A205823-004	AB

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 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A205823-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2016-09-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205823-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-09-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205823-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-09-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205823-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2016-09-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205823-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2016-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205823-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205823-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205823-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2016-09-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205823-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2016-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205823-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205823-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205823-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2016-09-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205823-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2016-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205823-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205823-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205823-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2016-09-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205823-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2016-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205823-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205823-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205823-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2016-09-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205823-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2016-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205823-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205823-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205823-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2016-09-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205823-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2016-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205823-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205823-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205823-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2016-09-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205823-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2016-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205823-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205823-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205823-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2016-09-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205823-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2016-09-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205823-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-09-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205823-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-09-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205823-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2016-09-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205823-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2016-09-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205823-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-09-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205823-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-09-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205823-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2016-09-15	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A205823-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205823-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205823-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205823-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205823-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205823-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205823-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205823-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205823-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205823-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205823-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205823-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205823-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205823-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205823-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205823-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205823-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205823-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205823-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205823-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205823-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205823-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205823-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205823-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205823-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205823-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205823-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205823-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205823-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205823-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205823-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205823-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205823-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205823-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205823-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205823-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205823-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205823-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205823-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205823-004	AB	1	`d8e5a09893c0…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
QUINAPRIL	QUINAPRIL	Bryant Ranch Prepack	fb069caa-14d0-4f76-b662-6145fb4cc276	2023-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205823 application number: ANDA205823 ndc (product): 71335-1134
QUINAPRIL	QUINAPRIL	Proficient Rx LP	1aafcf35-46cb-4a6f-81d4-821c599bdb71	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205823 application number: ANDA205823 ndc (product): 71205-484
QUINAPRIL	QUINAPRIL	Bryant Ranch Prepack	da84cb14-a9dd-4df0-a7e5-d5fbd84ac6da	2021-08-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205823 application number: ANDA205823 ndc (product): 63629-8710
QUINAPRIL	QUINAPRIL	Solco Healthcare US, LLC	cd46691d-5593-4a9f-a937-999c6803e312	2020-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205823 application number: ANDA205823 ndc (product): 43547-411 ndc (product): 43547-412 ndc (product): 43547-410 ndc (product): 43547-413

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43547-410	QUINAPRIL	quinapril	Solco Healthcare US, LLC	ANDA	Current
43547-410	QUINAPRIL	quinapril	Solco Healthcare US, LLC	ANDA	Current
43547-410	QUINAPRIL	quinapril	Solco Healthcare US, LLC	ANDA	Current
43547-411	QUINAPRIL	quinapril	Solco Healthcare US, LLC	ANDA	Current
43547-411	QUINAPRIL	quinapril	Solco Healthcare US, LLC	ANDA	Current
43547-411	QUINAPRIL	quinapril	Solco Healthcare US, LLC	ANDA	Current
43547-412	QUINAPRIL	quinapril	Solco Healthcare US, LLC	ANDA	Current
43547-412	QUINAPRIL	quinapril	Solco Healthcare US, LLC	ANDA	Current
43547-412	QUINAPRIL	quinapril	Solco Healthcare US, LLC	ANDA	Current
43547-413	QUINAPRIL	quinapril	Solco Healthcare US, LLC	ANDA	Current
43547-413	QUINAPRIL	quinapril	Solco Healthcare US, LLC	ANDA	Current
43547-413	QUINAPRIL	quinapril	Solco Healthcare US, LLC	ANDA	Current
50090-5400	QUINAPRIL	quinapril	A-S Medication Solutions	ANDA	Current
63629-8710	QUINAPRIL	quinapril	Bryant Ranch Prepack	ANDA	Current
70934-964	QUINAPRIL	quinapril	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71205-484	QUINAPRIL	quinapril	Proficient Rx LP	ANDA	Current
71205-484	QUINAPRIL	quinapril	Proficient Rx LP	ANDA	Current
71335-1134	QUINAPRIL	quinapril	Bryant Ranch Prepack	ANDA	Current
71335-1134	QUINAPRIL	quinapril	Bryant Ranch Prepack	ANDA	Current
71335-1134	QUINAPRIL	quinapril	Bryant Ranch Prepack	ANDA	Current
71335-1262	QUINAPRIL	quinapril	Bryant Ranch Prepack	ANDA	Current
71335-1262	QUINAPRIL	quinapril	Bryant Ranch Prepack	ANDA	Current