FDA.reportPublic FDA data

Application 022220

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRIVARISTRIAMCINOLONE ACETONIDEINJECTABLE;INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL8MG/0.1ML (8MG/0.1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022220-001TRIVARISTRIAMCINOLONE ACETONIDE8MG/0.1ML (8MG/0.1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREALRLD2008-06-16

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N022220-001TRIVARIS8MG/0.1ML (8MG/0.1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREALRLD2008-06-1684e616aacf4f…
2026-08-18 06:07:402026-07N022220-001TRIVARIS8MG/0.1ML (8MG/0.1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREALRLD2008-06-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022220-001TRIVARIS8MG/0.1ML (8MG/0.1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREALRLD2008-06-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022220-001TRIVARIS8MG/0.1ML (8MG/0.1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREALRLD2008-06-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N022220-001TRIVARIS8MG/0.1ML (8MG/0.1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREALRLD2008-06-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022220-001TRIVARIS8MG/0.1ML (8MG/0.1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREALRLD2008-06-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022220-001TRIVARIS8MG/0.1ML (8MG/0.1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREALRLD2008-06-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022220-001TRIVARIS8MG/0.1ML (8MG/0.1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREALRLD2008-06-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022220-001TRIVARIS8MG/0.1ML (8MG/0.1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREALRLD2008-06-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022220-001TRIVARIS8MG/0.1ML (8MG/0.1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREALRLD2008-06-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022220-001TRIVARIS8MG/0.1ML (8MG/0.1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREALRLD2008-06-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022220-001TRIVARIS8MG/0.1ML (8MG/0.1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREALRLD2008-06-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022220-001TRIVARIS8MG/0.1ML (8MG/0.1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREALRLD2008-06-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022220-001TRIVARIS8MG/0.1ML (8MG/0.1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREALRLD2008-06-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022220-001TRIVARIS8MG/0.1ML (8MG/0.1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREALRLD2008-06-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022220-001TRIVARIS8MG/0.1ML (8MG/0.1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREALRLD2008-06-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022220-001TRIVARIS8MG/0.1ML (8MG/0.1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREALRLD2008-06-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022220-001TRIVARIS8MG/0.1ML (8MG/0.1ML)INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREALRLD2008-06-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022220-001TRIVARIS8MG/0.1ML (8MG/0.1ML)INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREALRLD2008-06-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022220-001TRIVARIS8MG/0.1ML (8MG/0.1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREALRLD2008-06-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022220-001TRIVARIS8MG/0.1ML (8MG/0.1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREALRLD2008-06-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022220-001TRIVARIS8MG/0.1ML (8MG/0.1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREALRLD2008-06-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022220-001TRIVARIS8MG/0.1ML (8MG/0.1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREALRLD2008-06-1687673890dc5c…
2021-03-12 10:30 UTC2021-03N022220-001TRIVARIS8MG/0.1ML (8MG/0.1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREALRLD2008-06-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022220-001TRIVARIS8MG/0.1ML (8MG/0.1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREALRLD2008-06-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022220-001TRIVARIS8MG/0.1ML (8MG/0.1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREALRLD2008-06-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022220-001TRIVARIS8MG/0.1ML (8MG/0.1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREALRLD2008-06-163f01610625f2…
2019-09-15 20:21 UTC2019-09N022220-001TRIVARIS8MG/0.1ML (8MG/0.1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREALRLD2008-06-16b00525d2431f…
2019-07-19 19:46 UTC2019-07N022220-001TRIVARIS8MG/0.1ML (8MG/0.1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREALRLD2008-06-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022220-001TRIVARIS8MG/0.1ML (8MG/0.1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREALRLD2008-06-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022220-001TRIVARIS8MG/0.1ML (8MG/0.1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREALRLD2008-06-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022220-001TRIVARIS8MG/0.1ML (8MG/0.1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREALRLD2008-06-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022220-001TRIVARIS8MG/0.1ML (8MG/0.1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREALRLD2008-06-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022220-001TRIVARIS8MG/0.1ML (8MG/0.1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREALRLD2008-06-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022220-001TRIVARIS8MG/0.1ML (8MG/0.1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREALRLD2008-06-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022220-001TRIVARIS8MG/0.1ML (8MG/0.1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREALRLD2008-06-163f0d92c62455…
2023-05-13 08:27 UTC2023-05N022220-001TRIVARIS8MG/0.1ML (8MG/0.1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREALRLD2008-06-16053a50430f4f…
2023-01-26 05:58 UTC2023-01N022220-001TRIVARIS8MG/0.1ML (8MG/0.1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREALRLD2008-06-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022220-001TRIVARIS8MG/0.1ML (8MG/0.1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREALRLD2008-06-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022220-001TRIVARIS8MG/0.1ML (8MG/0.1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREALRLD2008-06-16f41ea6bd6efb…

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 8 of 11 · 208 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDENuCare Pharmaceuticals,Inc.8c4026de-9e91-c95d-e053-2a95a90a69032024-06-18Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
triamcinolone acetonideTRIAMCINOLONE ACETONIDEBryant Ranch Prepack107146d5-ffd2-4eb5-b75a-f814cd8407f02024-06-18Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEBryant Ranch Prepack658a80d1-1cd2-45a4-b097-6605c1ba31cd2024-06-18Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
triamcinolone acetonideTRIAMCINOLONE ACETONIDENuCare Pharmaceuticals,Inc.69aec845-3d4a-d226-e053-2991aa0afd122024-06-10Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDENuCare Pharmaceuticals,Inc.6a282425-8fdc-1fca-e053-2a91aa0a1c3a2024-06-10Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDENuCare Pharmaceuticals,Inc.6543d747-46a3-0502-e053-2991aa0aa0022024-06-06Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEBryant Ranch Prepackf85e36df-15d8-4b8f-94a5-39742d5728042024-05-31Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEA-S Medication Solutionsc3b09e80-67a7-4c5f-b324-2d8ecc9c054e2024-05-17Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEBryant Ranch Prepack2229a9e5-144f-42be-ab12-9c4f4163d22a2024-03-12Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEProficient Rx LP64d6a2f3-18cc-4ce4-8e75-4d77515e19112024-03-01Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEA-S Medication Solutions7889440c-4e82-4eb2-b5d3-7c4e0d5bdd8d2024-02-20Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEProficient Rx LPde5bad69-a014-4e25-b1b9-214373ca57a52024-02-01Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEBryant Ranch Prepackee274346-938b-4678-9146-486ca65bcba52024-01-15Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEBryant Ranch Prepack1e9007e8-fcd4-4aff-8d0a-4a43e0b8e6732024-01-12Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEBryant Ranch Prepack2adb56d4-2883-4060-b8cb-65a7662cfdda2024-01-12Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
Triloan II SUIKTRIAMCINOLONE ACETONIDEAsclemed USA, Inc.af3d002d-5e8e-44f6-bdd9-45a99263221b2024-01-09Warnings, Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone acetonideTRIAMCINOLONE ACETONIDEA-S Medication Solutionsb3d21abc-8952-45c3-b8cf-efa4dcce268d2023-12-28Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDENorthStar RxLLCcc60731e-6cef-44b1-903c-13c6f4a76e702023-12-25Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
triamcinolone acetonideTRIAMCINOLONE ACETONIDEA-S Medication Solutions2d6b9c2f-f1a0-413e-b333-64da523682022023-12-09Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEProficient Rx LP1bc85267-249f-4c55-9a8a-06d265263cb52023-12-01Adverse reactionsName 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
DocumentSubmission typeDate
21962ORIG2009-04-01
44706ORIG2008-07-17
29421ORIG2008-06-20
17099ORIG2008-06-19