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Details for New Drug Application (NDA): 208912
NDA 208912 describes DEXYCU KIT, which is a drug marketed by Eyepoint Pharms and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the DEXYCU KIT profile page.
The generic ingredient in DEXYCU KIT is dexamethasone. There are thirty-nine drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the dexamethasone profile page.
The generic ingredient in DEXYCU KIT is dexamethasone. There are thirty-nine drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the dexamethasone profile page.
Summary for 208912
| Tradename: | DEXYCU KIT |
| Applicant: | Eyepoint Pharms |
| Ingredient: | dexamethasone |
| Patents: | 5 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 208912
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 208912
Suppliers and Packaging for NDA: 208912
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEXYCU KIT | dexamethasone | SUSPENSION;INTRAOCULAR | 208912 | NDA | EyePoint Pharmaceuticals US, Inc | 71879-001 | 71879-001-01 | 1 VIAL, GLASS in 1 CARTON (71879-001-01) > .5 mL in 1 VIAL, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;INTRAOCULAR | Strength | 9% | ||||
| Approval Date: | Feb 9, 2018 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Feb 9, 2021 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | Start Trial | Patent Expiration: | Sep 12, 2020 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF POSTOPERATIVE INFLAMMATION | ||||||||
| Patent: | Start Trial | Patent Expiration: | May 23, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF POSTOPERATIVE INFLAMMATION | ||||||||
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