Details for New Drug Application (NDA): 210331

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NDA 210331 describes YUTIQ, which is a drug marketed by Alimera Sciences Inc and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug. Additional details are available on the YUTIQ profile page.

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

Summary for 210331

Tradename:	YUTIQ
Applicant:	Alimera Sciences Inc
Ingredient:	fluocinolone acetonide
Patents:	2

Pharmacology for NDA: 210331

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 210331

Anti-Inflammatory Agents
Glucocorticoids

Suppliers and Packaging for NDA: 210331

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
YUTIQ	fluocinolone acetonide	IMPLANT;INTRAVITREAL	210331	NDA	Alimera Sciences, Inc.	68611-180	68611-180-01	1 POUCH in 1 CARTON (68611-180-01) / 1 APPLICATOR in 1 POUCH / 1 IMPLANT in 1 APPLICATOR
YUTIQ	fluocinolone acetonide	IMPLANT;INTRAVITREAL	210331	NDA	EyePoint Pharmaceuticals, Inc	71879-136	71879-136-01	1 POUCH in 1 BOX, UNIT-DOSE (71879-136-01) / 1 APPLICATOR in 1 POUCH / 1 IMPLANT in 1 APPLICATOR

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	IMPLANT;INTRAVITREAL			Strength	0.18MG
Approval Date:	Oct 12, 2018	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Jan 12, 2028	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	A METHOD OF INJECTING AN IMPLANT
Patent:	⤷ Sign Up	Patent Expiration:	Aug 12, 2027	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 210331

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alimera Sciences Inc	YUTIQ	fluocinolone acetonide	IMPLANT;INTRAVITREAL	210331-001	Oct 12, 2018	⤷ Sign Up	⤷ Sign Up
Alimera Sciences Inc	YUTIQ	fluocinolone acetonide	IMPLANT;INTRAVITREAL	210331-001	Oct 12, 2018	⤷ Sign Up	⤷ Sign Up
Alimera Sciences Inc	YUTIQ	fluocinolone acetonide	IMPLANT;INTRAVITREAL	210331-001	Oct 12, 2018	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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