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Last Updated: November 20, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022315

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NDA 022315 describes OZURDEX, which is a drug marketed by Allergan and is included in one NDA. It is available from one supplier. There are sixteen patents protecting this drug. 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. Twenty-eight suppliers are listed for this compound. Additional details are available on the dexamethasone profile page.
Summary for 022315
Tradename:OZURDEX
Applicant:Allergan
Ingredient:dexamethasone
Patents:16
Formulation / Manufacturing:see details
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
Patent:  Start TrialPatent Expiration:Jan 9, 2023Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Oct 20, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF MACULAR EDEMA
Patent:  Start TrialPatent Expiration:Oct 20, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF UVEITIS

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