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 43.

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 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`3a93d1ddd44b…`
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…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
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…`
2019-12-13 00:20 UTC	2019-12	N208845-001	8828440	2031-08-04		Drug product	2017-10-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208845-001	9555048	2031-08-04	U-2151		2017-10-31	`74a2ff9319b5…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N208845-001	NP	2020-10-06	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N208845-001	NP	2020-10-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208845-001	NP	2020-10-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208845-001	NP	2020-10-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208845-001	NP	2020-10-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208845-001	NP	2020-10-06	`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.

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