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Last Updated: November 22, 2024

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-three 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
Medical Subject Heading (MeSH) Categories for 022315
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:RXDosage:IMPLANT;INTRAVITREALStrength0.7MG
Approval Date:Jun 17, 2009TE:RLD:Yes

Expired US Patents for NDA 022315

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie OZURDEX dexamethasone IMPLANT;INTRAVITREAL 022315-001 Jun 17, 2009 ⤷  Sign Up ⤷  Sign Up
Abbvie OZURDEX dexamethasone IMPLANT;INTRAVITREAL 022315-001 Jun 17, 2009 ⤷  Sign Up ⤷  Sign Up
Abbvie OZURDEX dexamethasone IMPLANT;INTRAVITREAL 022315-001 Jun 17, 2009 ⤷  Sign Up ⤷  Sign Up
Abbvie OZURDEX dexamethasone IMPLANT;INTRAVITREAL 022315-001 Jun 17, 2009 ⤷  Sign Up ⤷  Sign Up
Abbvie OZURDEX dexamethasone IMPLANT;INTRAVITREAL 022315-001 Jun 17, 2009 ⤷  Sign Up ⤷  Sign Up
Abbvie OZURDEX dexamethasone IMPLANT;INTRAVITREAL 022315-001 Jun 17, 2009 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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