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Last Updated: November 22, 2024

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 four 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. Forty-three 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:4
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:Oct 7, 2024
Regulatory Exclusivity Use:TREATMENT OF OCULAR ITCHING ASSOCIATED WITH ALLERGIC CONJUNCTIVITIS
Patent:⤷  Sign UpPatent Expiration:Nov 16, 2037Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF OCULAR INFLAMMATION AND PAIN FOLLOWING OPHTHALMIC SURGERY
Patent:⤷  Sign UpPatent Expiration:Nov 16, 2037Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF OCULAR ITCHING ASSOCIATED WITH ALLERGIC CONJUNCTIVITIS

Expired US Patents for NDA 208742

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ocular Therapeutix DEXTENZA dexamethasone INSERT;OPHTHALMIC 208742-001 Nov 30, 2018 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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