Details for New Drug Application (NDA): 208912

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NDA 208912 describes DEXYCU KIT, which is a drug marketed by Eyepoint Pharms and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the DEXYCU KIT profile page.

The generic ingredient in DEXYCU KIT is dexamethasone. There are thirty-nine drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the dexamethasone profile page.

Summary for 208912

Tradename:	DEXYCU KIT
Applicant:	Eyepoint Pharms
Ingredient:	dexamethasone
Patents:	5

Pharmacology for NDA: 208912

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 208912

Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents, Hormonal
Glucocorticoids

Suppliers and Packaging for NDA: 208912

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DEXYCU KIT	dexamethasone	SUSPENSION;INTRAOCULAR	208912	NDA	EyePoint Pharmaceuticals US, Inc	71879-001	71879-001-01	1 VIAL, GLASS in 1 CARTON (71879-001-01) / .5 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;INTRAOCULAR			Strength	9%
Approval Date:	Feb 9, 2018	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Jun 22, 2034	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF POSTOPERATIVE INFLAMMATION
Patent:	⤷ Sign Up	Patent Expiration:	May 23, 2034	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF POSTOPERATIVE INFLAMMATION
Patent:	⤷ Sign Up	Patent Expiration:	May 23, 2034	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 208912

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eyepoint Pharms	DEXYCU KIT	dexamethasone	SUSPENSION;INTRAOCULAR	208912-001	Feb 9, 2018	⤷ Sign Up	⤷ Sign Up
Eyepoint Pharms	DEXYCU KIT	dexamethasone	SUSPENSION;INTRAOCULAR	208912-001	Feb 9, 2018	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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