Details for New Drug Application (NDA): 208742
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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
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: | ⤷ Sign Up | Patent Expiration: | Nov 16, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF OCULAR INFLAMMATION AND PAIN FOLLOWING OPHTHALMIC SURGERY | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Nov 16, 2037 | Product 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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