Application 022048

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRIESENCE	TRIAMCINOLONE ACETONIDE	INJECTABLE;INTRAVITREAL	40MG/ML (40MG/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
N022048-001	TRIESENCE	TRIAMCINOLONE ACETONIDE	40MG/ML (40MG/ML)	INJECTABLE / INTRAVITREAL		RLD, RS	2007-11-29

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022048-001	8211880	2029-03-10	U-1257		2012-08-06
N022048-001	8211880	2029-03-10	U-1258		2012-08-06
N022048-001	8128960	2029-12-17		Drug product

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	N022048-001	TRIESENCE	40MG/ML (40MG/ML)	INJECTABLE / INTRAVITREAL	RLD, RS	2007-11-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022048-001	TRIESENCE	40MG/ML (40MG/ML)	INJECTABLE / INTRAVITREAL	RLD, RS	2007-11-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022048-001	TRIESENCE	40MG/ML (40MG/ML)	INJECTABLE / INTRAVITREAL	RLD, RS	2007-11-29	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022048-001	TRIESENCE	40MG/ML (40MG/ML)	INJECTABLE / INTRAVITREAL	RLD, RS	2007-11-29	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 138 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	N022048-001	8211880	2029-03-10	U-1258		2012-08-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022048-001	8211880	2029-03-10	U-1257		2012-08-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022048-001	8128960	2029-12-17		Drug product		`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022048-001	8211880	2029-03-10	U-1258		2012-08-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022048-001	8211880	2029-03-10	U-1257		2012-08-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022048-001	8128960	2029-12-17		Drug product		`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022048-001	8211880	2029-03-10	U-1258		2012-08-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022048-001	8211880	2029-03-10	U-1257		2012-08-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022048-001	8128960	2029-12-17		Drug product		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022048-001	8211880	2029-03-10	U-1258		2012-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022048-001	8211880	2029-03-10	U-1257		2012-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022048-001	8128960	2029-12-17		Drug product		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022048-001	8211880	2029-03-10	U-1258		2012-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022048-001	8211880	2029-03-10	U-1257		2012-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022048-001	8128960	2029-12-17		Drug product		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022048-001	8211880	2029-03-10	U-1258		2012-08-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022048-001	8211880	2029-03-10	U-1257		2012-08-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022048-001	8128960	2029-12-17		Drug product		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022048-001	8211880	2029-03-10	U-1258		2012-08-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022048-001	8211880	2029-03-10	U-1257		2012-08-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022048-001	8128960	2029-12-17		Drug product		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022048-001	8211880	2029-03-10	U-1258		2012-08-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022048-001	8211880	2029-03-10	U-1257		2012-08-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022048-001	8128960	2029-12-17		Drug product		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022048-001	8211880	2029-03-10	U-1258		2012-08-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022048-001	8211880	2029-03-10	U-1257		2012-08-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022048-001	8128960	2029-12-17		Drug product		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022048-001	8211880	2029-03-10	U-1258		2012-08-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022048-001	8211880	2029-03-10	U-1257		2012-08-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022048-001	8128960	2029-12-17		Drug product		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022048-001	8211880	2029-03-10	U-1258		2012-08-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022048-001	8211880	2029-03-10	U-1257		2012-08-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022048-001	8128960	2029-12-17		Drug product		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022048-001	8211880	2029-03-10	U-1258		2012-08-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022048-001	8211880	2029-03-10	U-1257		2012-08-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022048-001	8128960	2029-12-17		Drug product		`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022048-001	8211880	2029-03-10	U-1258		2012-08-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022048-001	8211880	2029-03-10	U-1257		2012-08-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022048-001	8128960	2029-12-17		Drug product		`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022048-001	8211880	2029-03-10	U-1258		2012-08-06	`79d66fd596c7…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TRIESENCE	TRIAMCINOLONE ACETONIDE	Harrow Eye, LLC	2267978c-72ad-9229-e063-6394a90a09d0	2026-06-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022048 application number: NDA022048
TRIESENCE	TRIAMCINOLONE ACETONIDE	Novartis Pharmaceuticals Corporation	22692d92-1359-9252-e063-6394a90ab669	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022048 application number: NDA022048

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
0065-0543	TRIESENCE	triamcinolone acetonide	Alcon Laboratories, Inc.	NDA	Current
0065-0543	TRIESENCE	triamcinolone acetonide	Alcon Laboratories, Inc.	NDA	Current
0065-0543	TRIESENCE	triamcinolone acetonide	Alcon Laboratories, Inc.	NDA	Current
0065-0543	TRIESENCE	triamcinolone acetonide	Alcon Laboratories, Inc.	NDA	Current
0065-0543	TRIESENCE	triamcinolone acetonide	Alcon Laboratories, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
42401	ORIG	2008-07-08
6771	ORIG	2008-01-09
38146	ORIG	2007-12-03
53427	ORIG	1900-01-01
53426	ORIG	1900-01-01
53425	ORIG	1900-01-01