Home Applications 022315 Application 022315
Type NDA
Sponsor ALLERGAN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 OZURDEX DEXAMETHASONE IMPLANT;INTRAVITREAL 0.7MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N022315-001 OZURDEX DEXAMETHASONE 0.7MG IMPLANT / INTRAVITREAL RLD, RS 2009-06-17
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 · 42 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 2026-08-18 06:07:40 2026-07 N022315-001 OZURDEX 0.7MG IMPLANT / INTRAVITREAL RLD, RS 2009-06-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022315-001 OZURDEX 0.7MG IMPLANT / INTRAVITREAL RLD, RS 2009-06-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022315-001 OZURDEX 0.7MG IMPLANT / INTRAVITREAL RLD, RS 2009-06-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022315-001 OZURDEX 0.7MG IMPLANT / INTRAVITREAL RLD, RS 2009-06-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022315-001 OZURDEX 0.7MG IMPLANT / INTRAVITREAL RLD, RS 2009-06-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022315-001 OZURDEX 0.7MG IMPLANT / INTRAVITREAL RLD, RS 2009-06-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022315-001 OZURDEX 0.7MG IMPLANT / INTRAVITREAL RLD, RS 2009-06-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022315-001 OZURDEX 0.7MG IMPLANT / INTRAVITREAL RLD, RS 2009-06-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022315-001 OZURDEX 0.7MG IMPLANT / INTRAVITREAL RLD, RS 2009-06-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022315-001 OZURDEX 0.7MG IMPLANT / INTRAVITREAL RLD, RS 2009-06-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022315-001 OZURDEX 0.7MG IMPLANT / INTRAVITREAL RLD, RS 2009-06-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022315-001 OZURDEX 0.7MG IMPLANT / INTRAVITREAL RLD, RS 2009-06-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022315-001 OZURDEX 0.7MG IMPLANT / INTRAVITREAL RLD, RS 2009-06-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022315-001 OZURDEX 0.7MG IMPLANT / INTRAVITREAL RLD, RS 2009-06-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022315-001 OZURDEX 0.7MG IMPLANT / INTRAVITREAL RLD, RS 2009-06-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022315-001 OZURDEX 0.7MG IMPLANT / INTRAVITREAL RLD, RS 2009-06-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022315-001 OZURDEX 0.7MG IMPLANT / INTRAVITREAL RLD, RS 2009-06-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022315-001 OZURDEX 0.7MG IMPLANT / INTRAVITREAL RLD, RS 2009-06-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022315-001 OZURDEX 0.7MG IMPLANT / INTRAVITREAL RLD, RS 2009-06-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022315-001 OZURDEX 0.7MG IMPLANT / INTRAVITREAL RLD, RS 2009-06-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022315-001 OZURDEX 0.7MG IMPLANT / INTRAVITREAL RLD, RS 2009-06-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022315-001 OZURDEX 0.7MG IMPLANT / INTRAVITREAL RLD, RS 2009-06-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022315-001 OZURDEX 0.7MG IMPLANT / INTRAVITREAL RLD, RS 2009-06-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022315-001 OZURDEX 0.7MG IMPLANT / INTRAVITREAL RLD, RS 2009-06-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022315-001 OZURDEX 0.7MG IMPLANT / INTRAVITREAL RLD, RS 2009-06-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022315-001 OZURDEX 0.7MG IMPLANT / INTRAVITREAL RLD, RS 2009-06-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022315-001 OZURDEX 0.7MG IMPLANT / INTRAVITREAL RLD, RS 2009-06-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022315-001 OZURDEX 0.7MG IMPLANT / INTRAVITREAL RLD, RS 2009-06-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022315-001 OZURDEX 0.7MG IMPLANT / INTRAVITREAL RLD, RS 2009-06-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022315-001 OZURDEX 0.7MG IMPLANT / INTRAVITREAL RLD, RS 2009-06-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022315-001 OZURDEX 0.7MG IMPLANT / INTRAVITREAL RLD, RS 2009-06-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022315-001 OZURDEX 0.7MG IMPLANT / INTRAVITREAL RLD, RS 2009-06-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022315-001 OZURDEX 0.7MG IMPLANT / INTRAVITREAL RLD, RS 2009-06-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022315-001 OZURDEX 0.7MG IMPLANT / INTRAVITREAL RLD, RS 2009-06-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022315-001 OZURDEX 0.7MG IMPLANT / INTRAVITREAL RLD, RS 2009-06-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022315-001 OZURDEX 0.7MG IMPLANT / INTRAVITREAL RLD, RS 2009-06-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022315-001 OZURDEX 0.7MG IMPLANT / INTRAVITREAL RLD, RS 2009-06-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022315-001 OZURDEX 0.7MG IMPLANT / INTRAVITREAL RLD, RS 2009-06-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022315-001 OZURDEX 0.7MG IMPLANT / INTRAVITREAL RLD, RS 2009-06-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022315-001 OZURDEX 0.7MG IMPLANT / INTRAVITREAL RLD, RS 2009-06-17 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 9 · 333 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022315-001 10076526 2023-01-09 Drug product 2018-10-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022315-001 10702539 2023-01-09 U-1597 2020-08-07 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022315-001 10702539 2023-01-09 U-985 2020-08-07 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022315-001 10702539 2023-01-09 U-2868 2020-08-07 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022315-001 8034366 2023-01-09 U-1205 Drug product 2011-12-23 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022315-001 8034366 2023-01-09 U-1204 Drug product 2011-12-23 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022315-001 8034370 2023-01-09 Drug product 2011-12-23 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022315-001 8506987 2023-01-09 U-1205 2013-09-11 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022315-001 8506987 2023-01-09 U-1204 2013-09-11 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022315-001 9192511 2023-01-09 Drug product 2015-12-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022315-001 6899717 2023-11-01 U-1206 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022315-001 10076526 2023-01-09 Drug product 2018-10-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022315-001 10702539 2023-01-09 U-1597 2020-08-07 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022315-001 10702539 2023-01-09 U-985 2020-08-07 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022315-001 10702539 2023-01-09 U-2868 2020-08-07 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022315-001 8034366 2023-01-09 U-1205 Drug product 2011-12-23 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022315-001 8034366 2023-01-09 U-1204 Drug product 2011-12-23 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022315-001 8034370 2023-01-09 Drug product 2011-12-23 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022315-001 8506987 2023-01-09 U-1205 2013-09-11 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022315-001 8506987 2023-01-09 U-1204 2013-09-11 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022315-001 9192511 2023-01-09 Drug product 2015-12-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022315-001 6899717 2023-11-01 U-1206 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022315-001 10076526 2023-01-09 Drug product 2018-10-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022315-001 10702539 2023-01-09 U-1597 2020-08-07 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022315-001 10702539 2023-01-09 U-985 2020-08-07 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022315-001 10702539 2023-01-09 U-2868 2020-08-07 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022315-001 8034366 2023-01-09 U-1205 Drug product 2011-12-23 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022315-001 8034366 2023-01-09 U-1204 Drug product 2011-12-23 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022315-001 8034370 2023-01-09 Drug product 2011-12-23 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022315-001 8506987 2023-01-09 U-1205 2013-09-11 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022315-001 8506987 2023-01-09 U-1204 2013-09-11 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022315-001 9192511 2023-01-09 Drug product 2015-12-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022315-001 6899717 2023-11-01 U-1206 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022315-001 6726918 2020-10-20 U-1204 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022315-001 6726918 2020-10-20 U-1205 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022315-001 7033605 2020-10-20 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022315-001 8043628 2020-10-20 U-1205 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022315-001 8063031 2020-10-20 Drug product 2011-12-23 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022315-001 8088407 2020-10-20 U-1205 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022315-001 9012437 2020-10-20 U-1205 2015-05-19 74a2ff9319b5…
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0023-3348 OZURDEX dexamethasone Allergan, Inc. NDA Current 0023-3348 OZURDEX dexamethasone Allergan, Inc. NDA Current 0023-3348 OZURDEX dexamethasone Allergan, Inc. NDA Current 0023-3348 OZURDEX dexamethasone Allergan, Inc. NDA Current 0023-3348 OZURDEX dexamethasone Allergan, Inc. NDA Current 0023-3348 OZURDEX dexamethasone Allergan, Inc. NDA Current