Application 078211

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 AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE	TABLET;ORAL	12.5MG;EQ 10MG BASE	No	No
002	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE	TABLET;ORAL	12.5MG;EQ 20MG BASE	No	No
003	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE	TABLET;ORAL	25MG;EQ 20MG 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A078211-001	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE	12.5MG;EQ 10MG BASE	TABLET / ORAL	2009-03-04
A078211-002	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE	12.5MG;EQ 20MG BASE	TABLET / ORAL	2009-03-04
A078211-003	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE	25MG;EQ 20MG BASE	TABLET / ORAL	2009-03-04

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 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A078211-001	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 10MG BASE	TABLET / ORAL	2009-03-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078211-002	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 20MG BASE	TABLET / ORAL	2009-03-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078211-003	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	25MG;EQ 20MG BASE	TABLET / ORAL	2009-03-04	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078211-001	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 10MG BASE	TABLET / ORAL	2009-03-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078211-002	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 20MG BASE	TABLET / ORAL	2009-03-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078211-003	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	25MG;EQ 20MG BASE	TABLET / ORAL	2009-03-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078211-001	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 10MG BASE	TABLET / ORAL	2009-03-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078211-002	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 20MG BASE	TABLET / ORAL	2009-03-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078211-003	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	25MG;EQ 20MG BASE	TABLET / ORAL	2009-03-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078211-001	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 10MG BASE	TABLET / ORAL	2009-03-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078211-002	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 20MG BASE	TABLET / ORAL	2009-03-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078211-003	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	25MG;EQ 20MG BASE	TABLET / ORAL	2009-03-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078211-001	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 10MG BASE	TABLET / ORAL	2009-03-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078211-002	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 20MG BASE	TABLET / ORAL	2009-03-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078211-003	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	25MG;EQ 20MG BASE	TABLET / ORAL	2009-03-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078211-001	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 10MG BASE	TABLET / ORAL	2009-03-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078211-002	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 20MG BASE	TABLET / ORAL	2009-03-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078211-003	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	25MG;EQ 20MG BASE	TABLET / ORAL	2009-03-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078211-001	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 10MG BASE	TABLET / ORAL	2009-03-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078211-002	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 20MG BASE	TABLET / ORAL	2009-03-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078211-003	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	25MG;EQ 20MG BASE	TABLET / ORAL	2009-03-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078211-001	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 10MG BASE	TABLET / ORAL	2009-03-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078211-002	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 20MG BASE	TABLET / ORAL	2009-03-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078211-003	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	25MG;EQ 20MG BASE	TABLET / ORAL	2009-03-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078211-001	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 10MG BASE	TABLET / ORAL	2009-03-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078211-002	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 20MG BASE	TABLET / ORAL	2009-03-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078211-003	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	25MG;EQ 20MG BASE	TABLET / ORAL	2009-03-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078211-001	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 10MG BASE	TABLET / ORAL	2009-03-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078211-002	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 20MG BASE	TABLET / ORAL	2009-03-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078211-003	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	25MG;EQ 20MG BASE	TABLET / ORAL	2009-03-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078211-001	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 10MG BASE	TABLET / ORAL	2009-03-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078211-002	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 20MG BASE	TABLET / ORAL	2009-03-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078211-003	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	25MG;EQ 20MG BASE	TABLET / ORAL	2009-03-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078211-001	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 10MG BASE	TABLET / ORAL	2009-03-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078211-002	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 20MG BASE	TABLET / ORAL	2009-03-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078211-003	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	25MG;EQ 20MG BASE	TABLET / ORAL	2009-03-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078211-001	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 10MG BASE	TABLET / ORAL	2009-03-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078211-002	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 20MG BASE	TABLET / ORAL	2009-03-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078211-003	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	25MG;EQ 20MG BASE	TABLET / ORAL	2009-03-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078211-001	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 10MG BASE	TABLET / ORAL	2009-03-04	`79d66fd596c7…`

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63304-161	Quinapril Hydrochloride and Hydrochlorothiazide	Quinapril Hydrochloride and Hydrochlorothiazide	Ranbaxy Pharmaceuticals Inc.	ANDA	Current
63304-162	Quinapril Hydrochloride and Hydrochlorothiazide	Quinapril Hydrochloride and Hydrochlorothiazide	Ranbaxy Pharmaceuticals Inc.	ANDA	Current
63304-163	Quinapril Hydrochloride and Hydrochlorothiazide	Quinapril Hydrochloride and Hydrochlorothiazide	Ranbaxy Pharmaceuticals Inc.	ANDA	Current