Application 211340

Type: NDA
Sponsor: SILVERGATE PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KATERZIA	AMLODIPINE BENZOATE	SUSPENSION;ORAL	EQ 1MG BASE/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
N211340-001	KATERZIA	AMLODIPINE BENZOATE	EQ 1MG BASE/ML	SUSPENSION / ORAL		RLD, RS	2019-07-08

Orange Book patents#

Current patent rows page 1 of 1 · 19 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N211340-001	10894039	2037-10-06	U-185		2021-02-16
N211340-001	10894039	2037-10-06	U-3		2021-02-16
N211340-001	10952998	2037-10-06		Drug product	2021-03-29
N211340-001	10959991	2037-10-06	U-158		2021-04-15
N211340-001	10959991	2037-10-06	U-39		2021-04-15
N211340-001	11364230	2037-10-06		Drug product	2022-06-24
N211340-001	11471409	2037-10-06	U-3447		2022-10-18
N211340-001	11471409	2037-10-06	U-3448		2022-10-18
N211340-001	11484498	2037-10-06		Drug product	2022-11-04
N211340-001	11701326	2037-10-06		Drug product	2023-07-20
N211340-001	11918685	2037-10-06	U-3447		2024-03-14
N211340-001	11918685	2037-10-06	U-3448		2024-03-14
N211340-001	12053461	2037-10-06		Drug product	2024-08-15
N211340-001	12336984	2037-10-06	U-3447		2025-06-27
N211340-001	12336984	2037-10-06	U-3448		2025-06-27
N211340-001	12383498	2037-10-06		Drug product	2025-10-29
N211340-001	12721843	2037-10-06		Drug product	2026-09-09
N211340-001	10695329	2037-10-16		Drug product	2020-07-22
N211340-001	10799453	2039-04-11		Drug product	2020-11-02

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-09-29 23:25 UTC	2022-09	N211340-001	KATERZIA	EQ 1MG BASE/ML	SUSPENSION / ORAL	RLD, RS	2019-07-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N211340-001	KATERZIA	EQ 1MG BASE/ML	SUSPENSION / ORAL	RLD, RS	2019-07-08	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N211340-001	KATERZIA	EQ 1MG BASE/ML	SUSPENSION / ORAL	RLD, RS	2019-07-08	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 12 · 472 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	N211340-001	10894039	2037-10-06	U-3		2021-02-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N211340-001	10894039	2037-10-06	U-185		2021-02-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N211340-001	10952998	2037-10-06		Drug product	2021-03-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N211340-001	10959991	2037-10-06	U-39		2021-04-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N211340-001	10959991	2037-10-06	U-158		2021-04-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N211340-001	11364230	2037-10-06		Drug product	2022-06-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N211340-001	11471409	2037-10-06	U-3447		2022-10-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N211340-001	11471409	2037-10-06	U-3448		2022-10-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N211340-001	11484498	2037-10-06		Drug product	2022-11-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N211340-001	11701326	2037-10-06		Drug product	2023-07-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N211340-001	11918685	2037-10-06	U-3447		2024-03-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N211340-001	11918685	2037-10-06	U-3448		2024-03-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N211340-001	12053461	2037-10-06		Drug product	2024-08-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N211340-001	12336984	2037-10-06	U-3447		2025-06-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N211340-001	12336984	2037-10-06	U-3448		2025-06-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N211340-001	12383498	2037-10-06		Drug product	2025-10-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N211340-001	12721843	2037-10-06		Drug product	2026-09-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N211340-001	10695329	2037-10-16		Drug product	2020-07-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N211340-001	10799453	2039-04-11		Drug product	2020-11-02	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N211340-001	10894039	2037-10-06	U-3		2021-02-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211340-001	10894039	2037-10-06	U-185		2021-02-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211340-001	10952998	2037-10-06		Drug product	2021-03-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211340-001	10959991	2037-10-06	U-39		2021-04-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211340-001	10959991	2037-10-06	U-158		2021-04-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211340-001	11364230	2037-10-06		Drug product	2022-06-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211340-001	11471409	2037-10-06	U-3447		2022-10-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211340-001	11471409	2037-10-06	U-3448		2022-10-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211340-001	11484498	2037-10-06		Drug product	2022-11-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211340-001	11701326	2037-10-06		Drug product	2023-07-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211340-001	11918685	2037-10-06	U-3447		2024-03-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211340-001	11918685	2037-10-06	U-3448		2024-03-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211340-001	12053461	2037-10-06		Drug product	2024-08-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211340-001	12336984	2037-10-06	U-3447		2025-06-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211340-001	12336984	2037-10-06	U-3448		2025-06-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211340-001	12383498	2037-10-06		Drug product	2025-10-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211340-001	12721843	2037-10-06		Drug product	2026-09-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211340-001	10695329	2037-10-16		Drug product	2020-07-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211340-001	10799453	2039-04-11		Drug product	2020-11-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N211340-001	10894039	2037-10-06	U-3		2021-02-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211340-001	10894039	2037-10-06	U-185		2021-02-16	`caaa826d4ba7…`

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
Katerzia	AMLODIPINE	Azurity Pharmaceuticals, Inc.	df673a4d-acb8-444c-a472-c87ab8cbd366	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211340 application number: NDA211340 ndc (product): 52652-5001

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
52652-5001	Katerzia	Amlodipine	Azurity Pharmaceuticals, Inc.	NDA	Current
52652-5001	Katerzia	Amlodipine	Azurity Pharmaceuticals, Inc.	NDA	Current
52652-5001	Katerzia	Amlodipine	Azurity Pharmaceuticals, Inc.	NDA	Current
52652-5001	Katerzia	Amlodipine	Silvergate Pharmaceuticals, Inc.	NDA	Current
52652-5001	Katerzia	Amlodipine	Azurity Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83032	SUPPL	2025-08-04
83031	SUPPL	2025-08-04
61582	ORIG	2020-01-16
59286	ORIG	2019-07-09
59285	ORIG	2019-07-08
62866	ORIG	1900-01-01
62865	ORIG	1900-01-01