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Last Updated: April 26, 2024

Details for New Drug Application (NDA): 201923

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NDA 201923 describes ILUVIEN, which is a drug marketed by Alimera Sciences Inc and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the ILUVIEN profile page.

The generic ingredient in ILUVIEN is fluocinolone acetonide. There are twelve drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.

Summary for 201923

Tradename:	ILUVIEN
Applicant:	Alimera Sciences Inc
Ingredient:	fluocinolone acetonide
Patents:	1
Formulation / Manufacturing:	see details

Pharmacology for NDA: 201923

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 201923

Anti-Inflammatory Agents
Glucocorticoids

Suppliers and Packaging for NDA: 201923

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ILUVIEN	fluocinolone acetonide	IMPLANT;INTRAVITREAL	201923	NDA	Alimera Sciences, Inc.	68611-190	68611-190-02	1 TRAY in 1 CARTON (68611-190-02) / 1 APPLICATOR in 1 TRAY / 1 IMPLANT in 1 APPLICATOR

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	IMPLANT;INTRAVITREAL			Strength	0.19MG
Approval Date:	Sep 26, 2014	TE:		RLD:	Yes
Patent:	⤷ Try a Trial	Patent Expiration:	Aug 12, 2027	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 201923

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alimera Sciences Inc	ILUVIEN	fluocinolone acetonide	IMPLANT;INTRAVITREAL	201923-001	Sep 26, 2014	⤷ Try a Trial	⤷ Try a Trial
Alimera Sciences Inc	ILUVIEN	fluocinolone acetonide	IMPLANT;INTRAVITREAL	201923-001	Sep 26, 2014	⤷ Try a Trial	⤷ Try a Trial
Alimera Sciences Inc	ILUVIEN	fluocinolone acetonide	IMPLANT;INTRAVITREAL	201923-001	Sep 26, 2014	⤷ Try a Trial	⤷ Try a Trial
Alimera Sciences Inc	ILUVIEN	fluocinolone acetonide	IMPLANT;INTRAVITREAL	201923-001	Sep 26, 2014	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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