Application 202725

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

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
A202725-001	QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2013-04-29
A202725-002	QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2013-04-29
A202725-003	QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2013-04-29
A202725-004	QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2013-04-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202725-001	AB
A202725-002	AB
A202725-003	AB
A202725-004	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	A202725-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2013-04-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202725-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2013-04-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202725-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2013-04-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202725-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2013-04-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202725-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2013-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202725-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2013-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202725-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2013-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202725-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2013-04-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202725-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2013-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202725-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2013-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202725-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2013-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202725-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2013-04-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202725-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2013-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202725-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2013-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202725-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2013-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202725-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2013-04-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202725-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2013-04-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202725-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2013-04-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202725-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2013-04-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202725-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2013-04-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202725-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2013-04-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202725-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2013-04-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202725-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2013-04-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202725-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2013-04-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202725-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2013-04-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202725-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2013-04-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202725-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2013-04-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202725-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2013-04-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202725-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2013-04-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202725-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2013-04-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202725-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2013-04-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202725-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2013-04-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202725-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2013-04-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202725-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2013-04-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202725-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2013-04-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202725-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2013-04-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202725-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2013-04-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202725-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2013-04-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202725-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2013-04-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202725-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2013-04-29	`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	A202725-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202725-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202725-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202725-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202725-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202725-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202725-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202725-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202725-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202725-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202725-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202725-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202725-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202725-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202725-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202725-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202725-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202725-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202725-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202725-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202725-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202725-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202725-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202725-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202725-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202725-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202725-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202725-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202725-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202725-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202725-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202725-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202725-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202725-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202725-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202725-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202725-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202725-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202725-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202725-004	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 · 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	Exact identifier application applno (ANDA): 202725 application number: ANDA202725 ndc (product): 63629-7934
Quinapril	QUINAPRIL HYDROCHLORIDE	Aurobindo Pharma Limited	93e6e668-5306-4f26-81d8-cbc3a7a5e787	2024-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202725 application number: ANDA202725 ndc (product): 65862-617 ndc (product): 65862-618 ndc (product): 65862-620 ndc (product): 65862-619
Quinapril	QUINAPRIL HYDROCHLORIDE	Proficient Rx LP	42e4f9dd-6032-4257-bd0f-8e9b71027f03	2020-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202725 application number: ANDA202725 ndc (product): 63187-874

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-2116	Quinapril	Quinapril Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2116	Quinapril	Quinapril Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2116	Quinapril	Quinapril Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2116	Quinapril	Quinapril Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2116	Quinapril	Quinapril Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2116	Quinapril	Quinapril Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2117	Quinapril	Quinapril Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2117	Quinapril	Quinapril Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2117	Quinapril	Quinapril Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2117	Quinapril	Quinapril Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2643	Quinapril	Quinapril Hydrochloride	A-S Medication Solutions	ANDA	Current
63187-874	Quinapril	Quinapril Hydrochloride	Proficient Rx LP	ANDA	Current
63187-874	Quinapril	Quinapril Hydrochloride	Proficient Rx LP	ANDA	Current
63187-874	Quinapril	Quinapril Hydrochloride	Proficient Rx LP	ANDA	Current
63629-7934	Quinapril	Quinapril Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-7934	Quinapril	Quinapril Hydrochloride	Bryant Ranch Prepack	ANDA	Current
65862-617	Quinapril	Quinapril Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-617	Quinapril	Quinapril Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-617	Quinapril	Quinapril Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-618	Quinapril	Quinapril Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-618	Quinapril	Quinapril Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-618	Quinapril	Quinapril Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-619	Quinapril	Quinapril Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-619	Quinapril	Quinapril Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-619	Quinapril	Quinapril Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-620	Quinapril	Quinapril Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-620	Quinapril	Quinapril Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-620	Quinapril	Quinapril Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
68071-3258	Quinapril	Quinapril Hydrochloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
68788-6894	Quinapril	Quinapril Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6894	Quinapril	Quinapril Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6894	Quinapril	Quinapril Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
70934-602	Quinapril	Quinapril Hydrochloride	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current