Details for New Drug Application (NDA): 022315

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NDA 022315 describes OZURDEX, which is a drug marketed by Abbvie and is included in one NDA. It is available from one supplier. Additional details are available on the OZURDEX profile page.

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

Summary for 022315

Tradename:	OZURDEX
Applicant:	Abbvie
Ingredient:	dexamethasone
Patents:	0

Pharmacology for NDA: 022315

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 022315

Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents, Hormonal
Glucocorticoids

Suppliers and Packaging for NDA: 022315

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OZURDEX	dexamethasone	IMPLANT;INTRAVITREAL	022315	NDA	Allergan, Inc.	0023-3348	0023-3348-07	1 POUCH in 1 CARTON (0023-3348-07) / 1 IMPLANT in 1 POUCH
OZURDEX	dexamethasone	IMPLANT;INTRAVITREAL	022315	NDA	Allergan, Inc.	0023-3348	0023-3348-08	1 POUCH in 1 CARTON (0023-3348-08) / 1 IMPLANT in 1 POUCH

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	IMPLANT;INTRAVITREAL			Strength	0.7MG
Approval Date:	Jun 17, 2009	TE:		RLD:	Yes

Expired US Patents for NDA 022315

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	OZURDEX	dexamethasone	IMPLANT;INTRAVITREAL	022315-001	Jun 17, 2009	9,592,242	⤷ Get Started Free
Abbvie	OZURDEX	dexamethasone	IMPLANT;INTRAVITREAL	022315-001	Jun 17, 2009	7,767,223	⤷ Get Started Free
Abbvie	OZURDEX	dexamethasone	IMPLANT;INTRAVITREAL	022315-001	Jun 17, 2009	9,192,511	⤷ Get Started Free
Abbvie	OZURDEX	dexamethasone	IMPLANT;INTRAVITREAL	022315-001	Jun 17, 2009	8,088,407	⤷ Get Started Free
Abbvie	OZURDEX	dexamethasone	IMPLANT;INTRAVITREAL	022315-001	Jun 17, 2009	10,076,526	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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