Details for New Drug Application (NDA): 218010
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NDA 218010 describes IDOSE TR, which is a drug marketed by Glaukos and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the IDOSE TR profile page.
The generic ingredient in IDOSE TR is travoprost. There are fifteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the travoprost profile page.
The generic ingredient in IDOSE TR is travoprost. There are fifteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the travoprost profile page.
Summary for 218010
| Tradename: | IDOSE TR |
| Applicant: | Glaukos |
| Ingredient: | travoprost |
| Patents: | 2 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 218010
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IDOSE TR | travoprost | IMPLANT;INTRACAMERAL | 218010 | NDA | Glaukos Corporation | 25357-100 | 25357-100-01 | 1 POUCH in 1 CARTON (25357-100-01) / 1 TRAY in 1 POUCH / 1 CANISTER in 1 TRAY / 1 IMPLANT in 1 CANISTER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | IMPLANT;INTRACAMERAL | Strength | 75MCG | ||||
| Approval Date: | Dec 13, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 13, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Oct 17, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Oct 17, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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