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-one suppliers are listed for this compound. Additional details are available on the dexamethasone profile page.
The generic ingredient in DEXTENZA is dexamethasone. There are thirty-nine drug master file entries for this compound. Forty-one 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 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 208742
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
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: | RX | Dosage: | INSERT;OPHTHALMIC | Strength | 0.4MG | ||||
| Approval Date: | Nov 30, 2018 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Oct 7, 2024 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF OCULAR ITCHING ASSOCIATED WITH ALLERGIC CONJUNCTIVITIS | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Nov 16, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF OCULAR INFLAMMATION AND PAIN FOLLOWING OPHTHALMIC SURGERY | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Nov 16, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF OCULAR ITCHING ASSOCIATED WITH ALLERGIC CONJUNCTIVITIS | ||||||||
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