Application 201923

Type: NDA
Sponsor: ALIMERA SCIENCES INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ILUVIEN	FLUOCINOLONE ACETONIDE	IMPLANT;INTRAVITREAL	0.19MG	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
N201923-001	ILUVIEN	FLUOCINOLONE ACETONIDE	0.19MG	IMPLANT / INTRAVITREAL		RLD, RS	2014-09-26

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N201923-001	8871241	2027-08-12		Drug product	2014-11-12
N201923-001	9849027	2028-11-07	U-4157	Drug product	2025-04-03
N201923-001	9849027	2028-11-07	U-708	Drug product	2025-04-03

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N201923-001	ILUVIEN	0.19MG	IMPLANT / INTRAVITREAL	RLD, RS	2014-09-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201923-001	ILUVIEN	0.19MG	IMPLANT / INTRAVITREAL	RLD, RS	2014-09-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201923-001	ILUVIEN	0.19MG	IMPLANT / INTRAVITREAL	RLD, RS	2014-09-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201923-001	ILUVIEN	0.19MG	IMPLANT / INTRAVITREAL	RLD, RS	2014-09-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201923-001	ILUVIEN	0.19MG	IMPLANT / INTRAVITREAL	RLD, RS	2014-09-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201923-001	ILUVIEN	0.19MG	IMPLANT / INTRAVITREAL	RLD, RS	2014-09-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201923-001	ILUVIEN	0.19MG	IMPLANT / INTRAVITREAL	RLD, RS	2014-09-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201923-001	ILUVIEN	0.19MG	IMPLANT / INTRAVITREAL	RLD, RS	2014-09-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201923-001	ILUVIEN	0.19MG	IMPLANT / INTRAVITREAL	RLD, RS	2014-09-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N201923-001	ILUVIEN	0.19MG	IMPLANT / INTRAVITREAL	RLD, RS	2014-09-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201923-001	ILUVIEN	0.19MG	IMPLANT / INTRAVITREAL	RLD, RS	2014-09-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201923-001	ILUVIEN	0.19MG	IMPLANT / INTRAVITREAL	RLD, RS	2014-09-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201923-001	ILUVIEN	0.19MG	IMPLANT / INTRAVITREAL	RLD, RS	2014-09-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N201923-001	ILUVIEN	0.19MG	IMPLANT / INTRAVITREAL	RLD, RS	2014-09-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201923-001	ILUVIEN	0.19MG	IMPLANT / INTRAVITREAL	RLD, RS	2014-09-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N201923-001	ILUVIEN	0.19MG	IMPLANT / INTRAVITREAL	RLD, RS	2014-09-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N201923-001	ILUVIEN	0.19MG	IMPLANT / INTRAVITREAL	RLD, RS	2014-09-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N201923-001	ILUVIEN	0.19MG	IMPLANT / INTRAVITREAL	RLD, RS	2014-09-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N201923-001	ILUVIEN	0.19MG	IMPLANT / INTRAVITREAL	RLD, RS	2014-09-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N201923-001	ILUVIEN	0.19MG	IMPLANT / INTRAVITREAL	RLD, RS	2014-09-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N201923-001	ILUVIEN	0.19MG	IMPLANT / INTRAVITREAL	RLD, RS	2014-09-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N201923-001	ILUVIEN	0.19MG	IMPLANT / INTRAVITREAL	RLD, RS	2014-09-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N201923-001	ILUVIEN	0.19MG	IMPLANT / INTRAVITREAL	RLD, RS	2014-09-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N201923-001	ILUVIEN	0.19MG	IMPLANT / INTRAVITREAL	RLD, RS	2014-09-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N201923-001	ILUVIEN	0.19MG	IMPLANT / INTRAVITREAL	RLD, RS	2014-09-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N201923-001	ILUVIEN	0.19MG	IMPLANT / INTRAVITREAL	RLD, RS	2014-09-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N201923-001	ILUVIEN	0.19MG	IMPLANT / INTRAVITREAL	RLD, RS	2014-09-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N201923-001	ILUVIEN	0.19MG	IMPLANT / INTRAVITREAL	RLD, RS	2014-09-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N201923-001	ILUVIEN	0.19MG	IMPLANT / INTRAVITREAL	RLD, RS	2014-09-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N201923-001	ILUVIEN	0.19MG	IMPLANT / INTRAVITREAL	RLD, RS	2014-09-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N201923-001	ILUVIEN	0.19MG	IMPLANT / INTRAVITREAL	RLD, RS	2014-09-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N201923-001	ILUVIEN	0.19MG	IMPLANT / INTRAVITREAL	RLD, RS	2014-09-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N201923-001	ILUVIEN	0.19MG	IMPLANT / INTRAVITREAL	RLD, RS	2014-09-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N201923-001	ILUVIEN	0.19MG	IMPLANT / INTRAVITREAL	RLD, RS	2014-09-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N201923-001	ILUVIEN	0.19MG	IMPLANT / INTRAVITREAL	RLD, RS	2014-09-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N201923-001	ILUVIEN	0.19MG	IMPLANT / INTRAVITREAL	RLD, RS	2014-09-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N201923-001	ILUVIEN	0.19MG	IMPLANT / INTRAVITREAL	RLD, RS	2014-09-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N201923-001	ILUVIEN	0.19MG	IMPLANT / INTRAVITREAL	RLD, RS	2014-09-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N201923-001	ILUVIEN	0.19MG	IMPLANT / INTRAVITREAL	RLD, RS	2014-09-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N201923-001	ILUVIEN	0.19MG	IMPLANT / INTRAVITREAL	RLD, RS	2014-09-26	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 67 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	N201923-001	8871241	2027-08-12		Drug product	2014-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201923-001	9849027	2028-11-07	U-708	Drug product	2025-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201923-001	9849027	2028-11-07	U-4157	Drug product	2025-04-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201923-001	8871241	2027-08-12		Drug product	2014-11-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201923-001	9849027	2028-11-07	U-708	Drug product	2025-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201923-001	9849027	2028-11-07	U-4157	Drug product	2025-04-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201923-001	8871241	2027-08-12		Drug product	2014-11-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201923-001	9849027	2028-11-07	U-708	Drug product	2025-04-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201923-001	9849027	2028-11-07	U-4157	Drug product	2025-04-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201923-001	8871241	2027-08-12		Drug product	2014-11-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201923-001	8871241	2027-08-12		Drug product	2014-11-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201923-001	8871241	2027-08-12		Drug product	2014-11-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201923-001	8871241	2027-08-12		Drug product	2014-11-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201923-001	8871241	2027-08-12		Drug product	2014-11-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201923-001	8871241	2027-08-12		Drug product	2014-11-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N201923-001	8871241	2027-08-12		Drug product	2014-11-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201923-001	8871241	2027-08-12		Drug product	2014-11-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201923-001	8871241	2027-08-12		Drug product	2014-11-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201923-001	8871241	2027-08-12		Drug product	2014-11-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N201923-001	8871241	2027-08-12		Drug product	2014-11-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201923-001	8871241	2027-08-12		Drug product	2014-11-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N201923-001	8871241	2027-08-12		Drug product	2014-11-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N201923-001	8871241	2027-08-12		Drug product	2014-11-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N201923-001	6217895	2019-03-22	U-1597	Drug product	2014-10-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N201923-001	6548078	2019-03-22	U-1597	Drug product	2014-10-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N201923-001	8252307	2019-06-27		Drug product	2014-10-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N201923-001	6375972	2020-04-26	U-1597	Drug product	2014-10-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N201923-001	8871241	2027-08-12		Drug product	2014-11-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N201923-001	8871241	2027-08-12		Drug product	2014-11-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N201923-001	8871241	2027-08-12		Drug product	2014-11-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N201923-001	8871241	2027-08-12		Drug product	2014-11-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N201923-001	8871241	2027-08-12		Drug product	2014-11-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N201923-001	6375972	2020-04-26	U-1597	Drug product	2014-10-23	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N201923-001	8871241	2027-08-12		Drug product	2014-11-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N201923-001	6375972	2020-04-26	U-1597	Drug product	2014-10-23	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N201923-001	8871241	2027-08-12		Drug product	2014-11-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N201923-001	6217895	2019-03-22	U-1597	Drug product	2014-10-23	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N201923-001	6548078	2019-03-22	U-1597	Drug product	2014-10-23	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N201923-001	8252307	2019-06-27		Drug product	2014-10-23	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N201923-001	6375972	2020-04-26	U-1597	Drug product	2014-10-23	`3f01610625f2…`

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
Iluvien	FLUOCINOLONE ACETONIDE	ANI Pharmaceuticals, Inc.	4400e471-7402-11df-93f2-0800200c9a66	2026-01-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 201923 application number: NDA201923 ndc (product): 68611-190

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
68611-190	Iluvien	fluocinolone acetonide	Alimera Sciences, Inc.	NDA	Current
68611-190	Iluvien	fluocinolone acetonide	Alimera Sciences, Inc.	NDA	Current
68611-190	Iluvien	fluocinolone acetonide	Alimera Sciences, Inc.	NDA	Current
68611-190	Iluvien	fluocinolone acetonide	Alimera Sciences, Inc.	NDA	Current
68611-190	Iluvien	fluocinolone acetonide	Alimera Sciences, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81582	SUPPL	2025-03-17
81562	SUPPL	2025-03-14
47563	SUPPL	2017-03-14
47514	SUPPL	2017-03-09
22865	ORIG	2016-03-18
40093	ORIG	2014-09-30
32148	ORIG	2014-09-29