Home Applications 208845 Application 208845
Type NDA
Sponsor FLEXION THERAPS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ZILRETTA TRIAMCINOLONE ACETONIDE FOR SUSPENSION, EXTENDED RELEASE;INTRA-ARTICULAR 32MG/VIAL Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 N208845-001 ZILRETTA TRIAMCINOLONE ACETONIDE 32MG/VIAL FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR RLD, RS 2017-10-06
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 N208845-001 8828440 2031-08-04 Drug product 2017-10-31 N208845-001 9555048 2031-08-04 U-2151 2017-10-31
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 2 of 2 · 44 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 2022-10-28 04:53 UTC 2022-10 N208845-001 ZILRETTA 32MG/VIAL FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR RLD, RS 2017-10-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208845-001 ZILRETTA 32MG/VIAL FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR RLD, RS 2017-10-06 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N208845-001 ZILRETTA 32MG/VIAL FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR RLD, RS 2017-10-06 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N208845-001 ZILRETTA 32MG/VIAL FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR RLD, RS 2017-10-06 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 88 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N208845-001 8828440 2031-08-04 Drug product 2017-10-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 N208845-001 9555048 2031-08-04 U-2151 2017-10-31 c2088c7a36db…2026-09-14 22:38:34 2026-08 N208845-001 8828440 2031-08-04 Drug product 2017-10-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208845-001 9555048 2031-08-04 U-2151 2017-10-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 N208845-001 8828440 2031-08-04 Drug product 2017-10-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208845-001 9555048 2031-08-04 U-2151 2017-10-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208845-001 8828440 2031-08-04 Drug product 2017-10-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208845-001 9555048 2031-08-04 U-2151 2017-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208845-001 8828440 2031-08-04 Drug product 2017-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208845-001 9555048 2031-08-04 U-2151 2017-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208845-001 8828440 2031-08-04 Drug product 2017-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208845-001 9555048 2031-08-04 U-2151 2017-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208845-001 8828440 2031-08-04 Drug product 2017-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208845-001 9555048 2031-08-04 U-2151 2017-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208845-001 8828440 2031-08-04 Drug product 2017-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208845-001 9555048 2031-08-04 U-2151 2017-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208845-001 8828440 2031-08-04 Drug product 2017-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208845-001 9555048 2031-08-04 U-2151 2017-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208845-001 8828440 2031-08-04 Drug product 2017-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208845-001 9555048 2031-08-04 U-2151 2017-10-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208845-001 8828440 2031-08-04 Drug product 2017-10-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208845-001 9555048 2031-08-04 U-2151 2017-10-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208845-001 8828440 2031-08-04 Drug product 2017-10-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208845-001 9555048 2031-08-04 U-2151 2017-10-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208845-001 8828440 2031-08-04 Drug product 2017-10-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N208845-001 9555048 2031-08-04 U-2151 2017-10-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208845-001 8828440 2031-08-04 Drug product 2017-10-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208845-001 9555048 2031-08-04 U-2151 2017-10-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208845-001 8828440 2031-08-04 Drug product 2017-10-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208845-001 9555048 2031-08-04 U-2151 2017-10-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208845-001 8828440 2031-08-04 Drug product 2017-10-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208845-001 9555048 2031-08-04 U-2151 2017-10-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208845-001 8828440 2031-08-04 Drug product 2017-10-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N208845-001 9555048 2031-08-04 U-2151 2017-10-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208845-001 8828440 2031-08-04 Drug product 2017-10-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208845-001 9555048 2031-08-04 U-2151 2017-10-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208845-001 8828440 2031-08-04 Drug product 2017-10-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N208845-001 9555048 2031-08-04 U-2151 2017-10-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208845-001 8828440 2031-08-04 Drug product 2017-10-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N208845-001 9555048 2031-08-04 U-2151 2017-10-31 4b0b4de00fa7…
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 Zilretta TRIAMCINOLONE ACETONIDE EXTENDED-RELEASE INJECTABLE SUSPENSION Pacira Pharmaceuticals, Inc. cd5c4673-21f2-4126-9556-da847b3a228b 2026-06-03 Warnings, Adverse reactions Exact identifier application applno (NDA): 208845 application number: NDA208845 ndc (product): 65250-003
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 65250-003 Zilretta triamcinolone acetonide extended-release injectable suspension Pacira Pharmaceuticals, Inc. NDA Current 70801-003 Zilretta triamcinolone acetonide extended-release injectable suspension Flexion Therapeutics, Inc. NDA Current 70801-003 Zilretta triamcinolone acetonide extended-release injectable suspension Flexion Therapeutics, Inc. NDA Current 70801-003 Zilretta triamcinolone acetonide extended-release injectable suspension Flexion Therapeutics, Inc. NDA Current 70801-003 Zilretta triamcinolone acetonide extended-release injectable suspension Flexion Therapeutics, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 80511 SUPPL 2024-12-05 80498 SUPPL 2024-12-04 79555 SUPPL 2024-09-06 79554 SUPPL 2024-09-06 65499 SUPPL 2020-12-04 65489 SUPPL 2020-12-03 61486 SUPPL 2019-12-31 61455 SUPPL 2019-12-26 53645 ORIG 2018-04-10 50022 ORIG 2017-10-12 49996 ORIG 2017-10-10