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Generated: May 26, 2017

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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 fourteen 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. Thirty-four suppliers are listed for this compound. Additional details are available on the dexamethasone profile page.

Summary for NDA: 022315

Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Inflammatory Bowel Disease Agents
Ophthalmic Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 022315

Suppliers and Packaging for NDA: 022315

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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:IMPLANT;INTRAVITREALStrength0.7MG
Approval Date:Jun 17, 2009TE:RLD:Yes
Patent:7,033,605Patent Expiration:Oct 20, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:7,767,223Patent Expiration:Nov 28, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:8,034,370Patent Expiration:Jan 9, 2023Product Flag?YSubstance Flag?Delist Request?

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