Details for New Drug Application (NDA): 205388
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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: | ⤷ Sign Up | Patent Expiration: | Jan 30, 2024 | Product Flag? | Substance Flag? | Delist Request? | |||
Patent: | ⤷ Sign Up | Patent Expiration: | Jan 30, 2024 | Product Flag? | Substance Flag? | Delist Request? | |||
Patent: | ⤷ Sign Up | 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 | ⤷ Sign Up | ⤷ Sign Up |
Rayner Surgical | OMIDRIA | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 205388-001 | May 30, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Rayner Surgical | OMIDRIA | ketorolac tromethamine; phenylephrine hydrochloride | SOLUTION;IRRIGATION | 205388-001 | May 30, 2014 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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