Application 076607

Type: ANDA
Sponsor: SUN PHARM INDS 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 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	Approval date
A076607-001	QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2004-12-15
A076607-002	QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2004-12-15
A076607-003	QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2004-12-15
A076607-004	QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2004-12-15

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 3 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A076607-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2004-12-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076607-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2004-12-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076607-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2004-12-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076607-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2004-12-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076607-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2004-12-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076607-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2004-12-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076607-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2004-12-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076607-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2004-12-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076607-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2004-12-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076607-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2004-12-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076607-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2004-12-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076607-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2004-12-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076607-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2004-12-15	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076607-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2004-12-15	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076607-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2004-12-15	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076607-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2004-12-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076607-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2004-12-15	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A076607-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2004-12-15	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A076607-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2004-12-15	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A076607-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2004-12-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076607-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2004-12-15	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A076607-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2004-12-15	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A076607-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2004-12-15	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A076607-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2004-12-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076607-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2004-12-15	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076607-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2004-12-15	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076607-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2004-12-15	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076607-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2004-12-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076607-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2004-12-15	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076607-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2004-12-15	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076607-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2004-12-15	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076607-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2004-12-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076607-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2004-12-15	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076607-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2004-12-15	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076607-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2004-12-15	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076607-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2004-12-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076607-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2004-12-15	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076607-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2004-12-15	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076607-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2004-12-15	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076607-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2004-12-15	`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

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63304-548	Quinapril	quinapril	Ranbaxy Pharmaceuticals Inc.	ANDA	Current
63304-549	Quinapril	quinapril	Ranbaxy Pharmaceuticals Inc.	ANDA	Current
63304-550	Quinapril	quinapril	Ranbaxy Pharmaceuticals Inc.	ANDA	Current
63304-551	Quinapril	quinapril	Ranbaxy Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8930	ORIG	2004-12-30