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Last Updated: July 7, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208742


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NDA 208742 describes DEXTENZA, which is a drug marketed by Ocular Therapeutix and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the DEXTENZA profile page.

The generic ingredient in DEXTENZA is dexamethasone. There are thirty-nine drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the dexamethasone profile page.
Summary for 208742
Tradename:DEXTENZA
Applicant:Ocular Therapeutix
Ingredient:dexamethasone
Patents:3
Formulation / Manufacturing:see details
Pharmacology for NDA: 208742
Medical Subject Heading (MeSH) Categories for 208742
Suppliers and Packaging for NDA: 208742
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXTENZA dexamethasone INSERT;OPHTHALMIC 208742 NDA Ocular Therapeutix, Inc. 70382-204 70382-204-01 1 POUCH in 1 BOX, UNIT-DOSE (70382-204-01) > 1 INSERT in 1 POUCH (70382-204-88)
DEXTENZA dexamethasone INSERT;OPHTHALMIC 208742 NDA Ocular Therapeutix, Inc. 70382-204 70382-204-10 10 POUCH in 1 BOX, UNIT-DOSE (70382-204-10) > 1 INSERT in 1 POUCH (70382-204-88)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INSERT;OPHTHALMICStrength0.4MG
Approval Date:Nov 30, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 30, 2021
Regulatory Exclusivity Use:NEW PRODUCT
Regulatory Exclusivity Expiration:Jun 20, 2022
Regulatory Exclusivity Use:TREATMENT OF OCULAR INFLAMMATION FOLLOWING OPHTHALMIC SURGERY
Patent:  Start TrialPatent Expiration:May 14, 2030Product Flag?YSubstance Flag?Delist Request?

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