Details for New Drug Application (NDA): 205388
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NDA 205388 describes OMIDRIA, which is a drug marketed by Rayner Surgical and is included in one NDA. It is available from two suppliers. There are seven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the OMIDRIA profile page.
The generic ingredient in OMIDRIA is ketorolac tromethamine; phenylephrine hydrochloride. There are eighteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine; phenylephrine hydrochloride profile page.
The generic ingredient in OMIDRIA is ketorolac tromethamine; phenylephrine hydrochloride. There are eighteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine; phenylephrine hydrochloride profile page.
Summary for 205388
| Tradename: | OMIDRIA |
| Applicant: | Rayner Surgical |
| Ingredient: | ketorolac tromethamine; phenylephrine hydrochloride |
| Patents: | 7 |
Pharmacology for NDA: 205388
| Mechanism of Action | Adrenergic alpha1-Agonists Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 205388
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OMIDRIA | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 205388 | NDA | Omeros Corporation | 62225-600 | 62225-600-00 | 1 VIAL in 1 CARTON (62225-600-00) / 4 mL in 1 VIAL |
| OMIDRIA | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 205388 | NDA | Omeros Corporation | 62225-600 | 62225-600-04 | 4 VIAL in 1 CARTON (62225-600-04) / 4 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;IRRIGATION | Strength | EQ 0.3% BASE;EQ 1% BASE | ||||
| Approval Date: | May 30, 2014 | TE: | AT | RLD: | Yes | ||||
| Patent: | 8,173,707*PED | Patent Expiration: | Jan 30, 2024 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patent: | 8,586,633*PED | Patent Expiration: | Jan 30, 2024 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patent: | 9,066,856*PED | Patent Expiration: | Apr 23, 2034 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 205388
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Rayner Surgical | OMIDRIA | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 205388-001 | May 30, 2014 | 8,173,707*PED | ⤷ Subscribe |
| Rayner Surgical | OMIDRIA | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 205388-001 | May 30, 2014 | 9,399,040*PED | ⤷ Subscribe |
| Rayner Surgical | OMIDRIA | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 205388-001 | May 30, 2014 | 9,278,101*PED | ⤷ Subscribe |
| Rayner Surgical | OMIDRIA | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 205388-001 | May 30, 2014 | 8,586,633*PED | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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