Application 022220

Type: NDA
Sponsor: ALLERGAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRIVARIS	TRIAMCINOLONE ACETONIDE	INJECTABLE;INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL	8MG/0.1ML (8MG/0.1ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N022220-001	TRIVARIS	TRIAMCINOLONE ACETONIDE	8MG/0.1ML (8MG/0.1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL		RLD	2008-06-16

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 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
2026-09-14 22:38:34	2026-08	N022220-001	TRIVARIS	8MG/0.1ML (8MG/0.1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL	RLD	2008-06-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022220-001	TRIVARIS	8MG/0.1ML (8MG/0.1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL	RLD	2008-06-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022220-001	TRIVARIS	8MG/0.1ML (8MG/0.1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL	RLD	2008-06-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022220-001	TRIVARIS	8MG/0.1ML (8MG/0.1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL	RLD	2008-06-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022220-001	TRIVARIS	8MG/0.1ML (8MG/0.1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL	RLD	2008-06-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022220-001	TRIVARIS	8MG/0.1ML (8MG/0.1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL	RLD	2008-06-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022220-001	TRIVARIS	8MG/0.1ML (8MG/0.1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL	RLD	2008-06-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022220-001	TRIVARIS	8MG/0.1ML (8MG/0.1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL	RLD	2008-06-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022220-001	TRIVARIS	8MG/0.1ML (8MG/0.1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL	RLD	2008-06-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022220-001	TRIVARIS	8MG/0.1ML (8MG/0.1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL	RLD	2008-06-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022220-001	TRIVARIS	8MG/0.1ML (8MG/0.1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL	RLD	2008-06-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022220-001	TRIVARIS	8MG/0.1ML (8MG/0.1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL	RLD	2008-06-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022220-001	TRIVARIS	8MG/0.1ML (8MG/0.1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL	RLD	2008-06-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022220-001	TRIVARIS	8MG/0.1ML (8MG/0.1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL	RLD	2008-06-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022220-001	TRIVARIS	8MG/0.1ML (8MG/0.1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL	RLD	2008-06-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022220-001	TRIVARIS	8MG/0.1ML (8MG/0.1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL	RLD	2008-06-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022220-001	TRIVARIS	8MG/0.1ML (8MG/0.1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL	RLD	2008-06-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022220-001	TRIVARIS	8MG/0.1ML (8MG/0.1ML)	INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL	RLD	2008-06-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022220-001	TRIVARIS	8MG/0.1ML (8MG/0.1ML)	INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL	RLD	2008-06-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022220-001	TRIVARIS	8MG/0.1ML (8MG/0.1ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL	RLD	2008-06-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022220-001	TRIVARIS	8MG/0.1ML (8MG/0.1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL	RLD	2008-06-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022220-001	TRIVARIS	8MG/0.1ML (8MG/0.1ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL	RLD	2008-06-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022220-001	TRIVARIS	8MG/0.1ML (8MG/0.1ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL	RLD	2008-06-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022220-001	TRIVARIS	8MG/0.1ML (8MG/0.1ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL	RLD	2008-06-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022220-001	TRIVARIS	8MG/0.1ML (8MG/0.1ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL	RLD	2008-06-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022220-001	TRIVARIS	8MG/0.1ML (8MG/0.1ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL	RLD	2008-06-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022220-001	TRIVARIS	8MG/0.1ML (8MG/0.1ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL	RLD	2008-06-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022220-001	TRIVARIS	8MG/0.1ML (8MG/0.1ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL	RLD	2008-06-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022220-001	TRIVARIS	8MG/0.1ML (8MG/0.1ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL	RLD	2008-06-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022220-001	TRIVARIS	8MG/0.1ML (8MG/0.1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL	RLD	2008-06-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022220-001	TRIVARIS	8MG/0.1ML (8MG/0.1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL	RLD	2008-06-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022220-001	TRIVARIS	8MG/0.1ML (8MG/0.1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL	RLD	2008-06-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022220-001	TRIVARIS	8MG/0.1ML (8MG/0.1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL	RLD	2008-06-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022220-001	TRIVARIS	8MG/0.1ML (8MG/0.1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL	RLD	2008-06-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022220-001	TRIVARIS	8MG/0.1ML (8MG/0.1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL	RLD	2008-06-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022220-001	TRIVARIS	8MG/0.1ML (8MG/0.1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL	RLD	2008-06-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022220-001	TRIVARIS	8MG/0.1ML (8MG/0.1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL	RLD	2008-06-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022220-001	TRIVARIS	8MG/0.1ML (8MG/0.1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL	RLD	2008-06-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022220-001	TRIVARIS	8MG/0.1ML (8MG/0.1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL	RLD	2008-06-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022220-001	TRIVARIS	8MG/0.1ML (8MG/0.1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL	RLD	2008-06-16	`f41ea6bd6efb…`

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 10 of 11 · 208 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Proficient Rx LP	4aa792cc-7cd4-4a98-8730-fa36feaa9b7a	2023-02-01	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triasil	TRIAMCINOLONE ACETONIDE	PureTek Corporation	dcf6c630-6f5d-3d2f-e053-2995a90ad812	2023-01-24	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	CMP Pharma, Inc.	5067e7da-3eed-4d6a-b870-47a35c3ded81	2023-01-17	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
KENALOG-40	TRIAMCINOLONE ACETONIDE	Proficient Rx LP	1ed85825-cd03-4b5b-9c9a-946653b5f71a	2023-01-01	Warnings, Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	Padagis Israel Pharmaceuticals Ltd	3cb47c24-b7eb-4709-8a41-cbeceadbc8d9	2023-01-01	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Cosette Pharmaceuticals, Inc.	b93b6763-446b-3277-497b-2ee50dcef80c	2022-11-30	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Cosette Pharmaceuticals, Inc.	d2095a36-3fcf-7c20-95e5-e046b014565f	2022-11-29	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Cosette Pharmaceuticals, Inc.	5b3bcc75-608d-23fd-91a5-0806d5fe32f5	2022-11-18	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Signature Care Nasal Allergy	TRIAMCINOLONE ACETONIDE	Safeway	65761d58-312a-4ae9-b75b-2fe3fa5f7092	2022-11-15	Warnings	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Nasal Allergy	TRIAMCINOLONE ACETONIDE	H E B	faaa9219-2673-485e-bd84-71bdb23b3e47	2022-11-12	Warnings	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Proficient Rx LP	5bb59e27-c49a-4543-bdca-c2070e90e162	2022-11-01	Warnings, Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Nasal Allergy	TRIAMCINOLONE ACETONIDE	CVS Pharmacy	8c236d9d-2dee-40fc-adac-9d17a5eace9e	2022-10-24	Warnings	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Basic Care Nasal Allergy	TRIAMCINOLONE ACETONIDE	Amazon.com Services LLC	a7bc5220-3a75-4bb7-a6a2-3a73fbd99d87	2022-10-13	Warnings	Name fallback generic name: TRIAMCINOLONE ACETONIDE
DG Health Nasal Allergy	TRIAMCINOLONE ACETONIDE	Dolgencorp, LLC	6d326caa-40e7-4406-8768-f247f0777055	2022-10-13	Warnings	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Equate Nasal Allergy	TRIAMCINOLONE ACETONIDE	Wal-Mart Stores Inc	bdcbaba4-8f16-40ad-862f-9f0bc450ab87	2022-10-12	Warnings	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	Proficient Rx LP	7a2392c6-d26f-4def-8c7d-8b79e384c522	2022-10-01	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Proficient Rx LP	b05fddfb-7d63-42d8-b41a-003492d3922c	2022-09-01	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Proficient Rx LP	c91aaf91-afd9-4f0a-9634-6ed83763aa7c	2022-06-01	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triloan SUIK	TRIAMCINOLONE ACETONIDE	Asclemed USA, Inc.	320f7f0c-177c-42dc-96e6-4d688677c57a	2022-05-20	Warnings, Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Proficient Rx LP	63b51d50-7eb9-4687-965c-d4c57afc4030	2022-04-01	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
21962	ORIG	2009-04-01
44706	ORIG	2008-07-17
29421	ORIG	2008-06-20
17099	ORIG	2008-06-19