Application 208401

Type: NDA
Sponsor: SILVERGATE PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	QBRELIS	LISINOPRIL	SOLUTION;ORAL	1MG/ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N208401-001	QBRELIS	LISINOPRIL	1MG/ML	SOLUTION / ORAL	AA	RLD, RS	2016-07-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N208401-001	AA

Orange Book patents#

Current patent rows page 1 of 1 · 32 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208401-001	10039800	2035-11-06	U-1723		2018-08-23
N208401-001	10039800	2035-11-06	U-185		2018-08-23
N208401-001	10039800	2035-11-06	U-1864		2018-08-23
N208401-001	10039800	2035-11-06	U-1991		2018-08-23
N208401-001	10039800	2035-11-06	U-3		2018-08-23
N208401-001	10039800	2035-11-06	U-71		2018-08-23
N208401-001	10039800	2035-11-06	U-8		2018-08-23
N208401-001	10265370	2035-11-06		Drug product	2019-04-29
N208401-001	10406199	2035-11-06	U-1723		2019-09-20
N208401-001	10406199	2035-11-06	U-185		2019-09-20
N208401-001	10406199	2035-11-06	U-1864		2019-09-20
N208401-001	10406199	2035-11-06	U-1991		2019-09-20
N208401-001	10406199	2035-11-06	U-3		2019-09-20
N208401-001	10406199	2035-11-06	U-71		2019-09-20
N208401-001	10406199	2035-11-06	U-8		2019-09-20
N208401-001	10940177	2035-11-06		Drug product	2021-03-15
N208401-001	11179434	2035-11-06		Drug product	2021-11-23
N208401-001	11771733	2035-11-06		Drug product	2023-10-04
N208401-001	12128083	2035-11-06		Drug product	2024-11-12
N208401-001	12186360	2035-11-06		Drug product	2025-01-15
N208401-001	12433931	2035-11-06	U-1723		2025-10-09
N208401-001	12433931	2035-11-06	U-1864		2025-10-09
N208401-001	12433931	2035-11-06	U-3		2025-10-09
N208401-001	9463183	2035-11-06		Drug product	2016-10-13
N208401-001	9616096	2035-11-06	U-1723		2017-04-14
N208401-001	9616096	2035-11-06	U-185		2017-04-14
N208401-001	9616096	2035-11-06	U-1864		2017-04-14
N208401-001	9616096	2035-11-06	U-1991		2017-04-14
N208401-001	9616096	2035-11-06	U-3		2017-04-14
N208401-001	9616096	2035-11-06	U-71		2017-04-14
N208401-001	9616096	2035-11-06	U-8		2017-04-14
N208401-001	9814751	2035-11-06		Drug product	2017-11-21

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N208401-001	QBRELIS	1MG/ML	SOLUTION / ORAL	RLD, RS	2016-07-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208401-001	QBRELIS	1MG/ML	SOLUTION / ORAL	RLD, RS	2016-07-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208401-001	QBRELIS	1MG/ML	SOLUTION / ORAL	RLD, RS	2016-07-29	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208401-001	QBRELIS	1MG/ML	SOLUTION / ORAL	RLD, RS	2016-07-29	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N208401-001	AA	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N208401-001	AA	1	`84e616aacf4f…`

Observed Orange Book patent history#

Patent history page 1 of 30 · 1,176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N208401-001	10039800	2035-11-06	U-8		2018-08-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208401-001	10039800	2035-11-06	U-1864		2018-08-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208401-001	10039800	2035-11-06	U-1991		2018-08-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208401-001	10039800	2035-11-06	U-71		2018-08-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208401-001	10039800	2035-11-06	U-1723		2018-08-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208401-001	10039800	2035-11-06	U-3		2018-08-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208401-001	10039800	2035-11-06	U-185		2018-08-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208401-001	10265370	2035-11-06		Drug product	2019-04-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208401-001	10406199	2035-11-06	U-1864		2019-09-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208401-001	10406199	2035-11-06	U-185		2019-09-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208401-001	10406199	2035-11-06	U-1723		2019-09-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208401-001	10406199	2035-11-06	U-71		2019-09-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208401-001	10406199	2035-11-06	U-1991		2019-09-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208401-001	10406199	2035-11-06	U-3		2019-09-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208401-001	10406199	2035-11-06	U-8		2019-09-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208401-001	10940177	2035-11-06		Drug product	2021-03-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208401-001	11179434	2035-11-06		Drug product	2021-11-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208401-001	11771733	2035-11-06		Drug product	2023-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208401-001	12128083	2035-11-06		Drug product	2024-11-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208401-001	12186360	2035-11-06		Drug product	2025-01-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208401-001	12433931	2035-11-06	U-1723		2025-10-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208401-001	12433931	2035-11-06	U-1864		2025-10-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208401-001	12433931	2035-11-06	U-3		2025-10-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208401-001	9463183	2035-11-06		Drug product	2016-10-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208401-001	9616096	2035-11-06	U-3		2017-04-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208401-001	9616096	2035-11-06	U-185		2017-04-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208401-001	9616096	2035-11-06	U-1723		2017-04-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208401-001	9616096	2035-11-06	U-1864		2017-04-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208401-001	9616096	2035-11-06	U-1991		2017-04-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208401-001	9616096	2035-11-06	U-8		2017-04-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208401-001	9616096	2035-11-06	U-71		2017-04-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208401-001	9814751	2035-11-06		Drug product	2017-11-21	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N208401-001	10039800	2035-11-06	U-8		2018-08-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208401-001	10039800	2035-11-06	U-1864		2018-08-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208401-001	10039800	2035-11-06	U-1991		2018-08-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208401-001	10039800	2035-11-06	U-71		2018-08-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208401-001	10039800	2035-11-06	U-1723		2018-08-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208401-001	10039800	2035-11-06	U-3		2018-08-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208401-001	10039800	2035-11-06	U-185		2018-08-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208401-001	10265370	2035-11-06		Drug product	2019-04-29	`84e616aacf4f…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Qbrelis	LISINOPRIL	Azurity Pharmaceuticals, Inc.	9f6e4e57-a489-4b36-b093-b93865d3717c	2025-12-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 208401 application number: NDA208401 ndc (product): 52652-3001

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
52652-3001	Qbrelis	lisinopril	Silvergate Pharmaceuticals, Inc.	NDA	Current
52652-3001	Qbrelis	lisinopril	Azurity Pharmaceuticals, Inc.	NDA	Current
52652-3001	Qbrelis	lisinopril	Azurity Pharmaceuticals, Inc.	NDA	Current
52652-3001	Qbrelis	lisinopril	Silvergate Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
49185	SUPPL	2017-08-02
49153	SUPPL	2017-07-31
46455	ORIG	2016-12-21
19993	ORIG	2016-08-02
10654	ORIG	2016-08-02