Home Applications 021737 Application 021737
Type NDA
Sponsor BAUSCH AND LOMB Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 RETISERT FLUOCINOLONE ACETONIDE IMPLANT;INTRAVITREAL 0.59MG 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 N021737-001 RETISERT FLUOCINOLONE ACETONIDE 0.59MG IMPLANT / INTRAVITREAL RLD 2005-04-08
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 N021737-001 RETISERT 0.59MG IMPLANT / INTRAVITREAL RLD, RS 2005-04-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021737-001 RETISERT 0.59MG IMPLANT / INTRAVITREAL RLD, RS 2005-04-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021737-001 RETISERT 0.59MG IMPLANT / INTRAVITREAL RLD, RS 2005-04-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021737-001 RETISERT 0.59MG IMPLANT / INTRAVITREAL RLD, RS 2005-04-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021737-001 RETISERT 0.59MG IMPLANT / INTRAVITREAL RLD, RS 2005-04-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021737-001 RETISERT 0.59MG IMPLANT / INTRAVITREAL RLD, RS 2005-04-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021737-001 RETISERT 0.59MG IMPLANT / INTRAVITREAL RLD, RS 2005-04-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021737-001 RETISERT 0.59MG IMPLANT / INTRAVITREAL RLD, RS 2005-04-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021737-001 RETISERT 0.59MG IMPLANT / INTRAVITREAL RLD, RS 2005-04-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021737-001 RETISERT 0.59MG IMPLANT / INTRAVITREAL RLD, RS 2005-04-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021737-001 RETISERT 0.59MG IMPLANT / INTRAVITREAL RLD, RS 2005-04-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021737-001 RETISERT 0.59MG IMPLANT / INTRAVITREAL RLD, RS 2005-04-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021737-001 RETISERT 0.59MG IMPLANT / INTRAVITREAL RLD, RS 2005-04-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021737-001 RETISERT 0.59MG IMPLANT / INTRAVITREAL RLD, RS 2005-04-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021737-001 RETISERT 0.59MG IMPLANT / INTRAVITREAL RLD, RS 2005-04-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021737-001 RETISERT 0.59MG IMPLANT / INTRAVITREAL RLD, RS 2005-04-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021737-001 RETISERT 0.59MG IMPLANT / INTRAVITREAL RLD, RS 2005-04-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021737-001 RETISERT 0.59MG IMPLANT / INTRAVITREAL RLD, RS 2005-04-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021737-001 RETISERT 0.59MG IMPLANT / INTRAVITREAL RLD, RS 2005-04-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021737-001 RETISERT 0.59MG IMPLANT / INTRAVITREAL RLD, RS 2005-04-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021737-001 RETISERT 0.59MG IMPLANT / INTRAVITREAL RLD, RS 2005-04-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021737-001 RETISERT 0.59MG IMPLANT / INTRAVITREAL RLD, RS 2005-04-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021737-001 RETISERT 0.59MG IMPLANT / INTRAVITREAL RLD, RS 2005-04-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021737-001 RETISERT 0.59MG IMPLANT / INTRAVITREAL RLD, RS 2005-04-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021737-001 RETISERT 0.59MG IMPLANT / INTRAVITREAL RLD, RS 2005-04-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021737-001 RETISERT 0.59MG IMPLANT / INTRAVITREAL RLD, RS 2005-04-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021737-001 RETISERT 0.59MG IMPLANT / INTRAVITREAL RLD, RS 2005-04-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021737-001 RETISERT 0.59MG IMPLANT / INTRAVITREAL RLD, RS 2005-04-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021737-001 RETISERT 0.59MG IMPLANT / INTRAVITREAL RLD, RS 2005-04-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021737-001 RETISERT 0.59MG IMPLANT / INTRAVITREAL RLD, RS 2005-04-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021737-001 RETISERT 0.59MG IMPLANT / INTRAVITREAL RLD, RS 2005-04-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021737-001 RETISERT 0.59MG IMPLANT / INTRAVITREAL RLD, RS 2005-04-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021737-001 RETISERT 0.59MG IMPLANT / INTRAVITREAL RLD, RS 2005-04-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021737-001 RETISERT 0.59MG IMPLANT / INTRAVITREAL RLD, RS 2005-04-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021737-001 RETISERT 0.59MG IMPLANT / INTRAVITREAL RLD, RS 2005-04-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021737-001 RETISERT 0.59MG IMPLANT / INTRAVITREAL RLD, RS 2005-04-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021737-001 RETISERT 0.59MG IMPLANT / INTRAVITREAL RLD, RS 2005-04-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021737-001 RETISERT 0.59MG IMPLANT / INTRAVITREAL RLD, RS 2005-04-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021737-001 RETISERT 0.59MG IMPLANT / INTRAVITREAL RLD, RS 2005-04-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021737-001 RETISERT 0.59MG IMPLANT / INTRAVITREAL RLD, RS 2005-04-08 cb3db0bc1861…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021737-001 6217895 2019-03-22 U-708 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021737-001 6548078 2019-03-22 U-708 Drug product 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N021737-001 6217895 2019-03-22 U-708 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021737-001 6548078 2019-03-22 U-708 Drug product 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021737-001 6217895 2019-03-22 U-708 Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021737-001 6548078 2019-03-22 U-708 Drug product b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021737-001 6217895 2019-03-22 U-708 Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021737-001 6548078 2019-03-22 U-708 Drug product ea99ee380514…
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 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 24208-416 Retisert Fluocinolone Acetonide Bausch & Lomb Incorporated NDA Current 24208-416 Retisert Fluocinolone Acetonide Bausch & Lomb Incorporated NDA Current 24208-416 Retisert Fluocinolone Acetonide Bausch & Lomb Incorporated NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 81889 SUPPL 2025-04-08 81829 SUPPL 2025-04-07 16284 SUPPL 2011-06-07 6089 SUPPL 2011-06-06 6088 SUPPL 2010-12-03 28496 SUPPL 2008-08-07 28495 SUPPL 2007-11-08 37558 SUPPL 2007-11-07 42291 ORIG 2007-01-22 16283 ORIG 2005-04-12 6087 ORIG 2005-04-12