Home Applications 210331 Application 210331
Type NDA
Sponsor EYEPOINT PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 YUTIQ FLUOCINOLONE ACETONIDE IMPLANT;INTRAVITREAL 0.18MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N210331-001 YUTIQ FLUOCINOLONE ACETONIDE 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N210331-001 8871241 2027-08-12 Drug product 2018-11-01 N210331-001 7998108 2028-01-12 U-3410 Drug product 2022-09-09
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 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 3 · 109 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N210331-001 8871241 2027-08-12 Drug product 2018-11-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210331-001 7998108 2028-01-12 U-3410 Drug product 2022-09-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210331-001 8871241 2027-08-12 Drug product 2018-11-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210331-001 7998108 2028-01-12 U-3410 Drug product 2022-09-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210331-001 8871241 2027-08-12 Drug product 2018-11-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210331-001 7998108 2028-01-12 U-3410 Drug product 2022-09-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210331-001 8871241 2027-08-12 Drug product 2018-11-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210331-001 7998108 2028-01-12 U-3410 Drug product 2022-09-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210331-001 8871241 2027-08-12 Drug product 2018-11-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210331-001 7998108 2028-01-12 U-3410 Drug product 2022-09-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210331-001 8871241 2027-08-12 Drug product 2018-11-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210331-001 7998108 2028-01-12 U-3410 Drug product 2022-09-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210331-001 8871241 2027-08-12 Drug product 2018-11-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210331-001 7998108 2028-01-12 U-3410 Drug product 2022-09-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210331-001 8871241 2027-08-12 Drug product 2018-11-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210331-001 7998108 2028-01-12 U-3410 Drug product 2022-09-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210331-001 8871241 2027-08-12 Drug product 2018-11-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210331-001 7998108 2028-01-12 U-3410 Drug product 2022-09-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210331-001 8871241 2027-08-12 Drug product 2018-11-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210331-001 7998108 2028-01-12 U-3410 Drug product 2022-09-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210331-001 8871241 2027-08-12 Drug product 2018-11-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210331-001 7998108 2028-01-12 U-3410 Drug product 2022-09-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210331-001 8871241 2027-08-12 Drug product 2018-11-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210331-001 7998108 2028-01-12 U-3410 Drug product 2022-09-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210331-001 8871241 2027-08-12 Drug product 2018-11-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210331-001 7998108 2028-01-12 U-3410 Drug product 2022-09-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210331-001 8871241 2027-08-12 Drug product 2018-11-01 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N210331-001 7998108 2028-01-12 U-3410 Drug product 2022-09-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210331-001 8871241 2027-08-12 Drug product 2018-11-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210331-001 8871241 2027-08-12 Drug product 2018-11-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210331-001 8871241 2027-08-12 Drug product 2018-11-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210331-001 6217895 2019-03-22 U-708 Drug product 2018-11-01 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N210331-001 6548078 2019-03-22 U-708 Drug product 2018-11-01 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N210331-001 8252307 2019-06-27 Drug product 2018-11-01 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N210331-001 6375972 2020-04-26 U-708 Drug product 2018-11-01 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N210331-001 8574613 2020-04-26 Drug product 2018-11-01 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N210331-001 8574659 2020-04-26 Drug product 2018-11-01 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N210331-001 9192579 2020-04-26 Drug product 2018-11-01 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N210331-001 9849085 2020-04-26 U-708 2018-11-01 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N210331-001 8871241 2027-08-12 Drug product 2018-11-01 74a2ff9319b5…
Observed Orange Book exclusivity history# 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 YUTIQ FLUOCINOLONE ACETONIDE ANI Pharmaceuticals, Inc. f270cad8-ed82-4969-b785-831a1910bfa6 2026-02-19 Warnings, Adverse reactions Exact identifier application applno (NDA): 210331 application number: NDA210331
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 71879-136 YUTIQ fluocinolone acetonide EyePoint Pharmaceuticals, Inc NDA Current 71879-136 YUTIQ fluocinolone acetonide EyePoint Pharmaceuticals US, Inc NDA Current 71879-136 YUTIQ fluocinolone acetonide EyePoint Pharmaceuticals, Inc NDA Current 71879-136 YUTIQ fluocinolone acetonide EyePoint Pharmaceuticals, Inc NDA Current 71879-136 YUTIQ fluocinolone acetonide EyePoint Pharmaceuticals, Inc NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 58213 ORIG 2019-04-04 55972 ORIG 2018-10-17