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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Baxter
Cerilliant
Deloitte
Queensland Health
Farmers Insurance
QuintilesIMS
Citi
Argus Health

Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205388

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NDA 205388 describes OMIDRIA, which is a drug marketed by Omeros and is included in one NDA. It is available from one supplier. 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. One supplier is listed for this compound. Additional details are available on the ketorolac tromethamine; phenylephrine hydrochloride profile page.
Summary for 205388
Tradename:OMIDRIA
Applicant:Omeros
Ingredient:ketorolac tromethamine; phenylephrine hydrochloride
Patents:7
Formulation / Manufacturing:see details
Pharmacology for NDA: 205388
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 N 62225-600-00
OMIDRIA ketorolac tromethamine; phenylephrine hydrochloride SOLUTION;IRRIGATION 205388 NDA Omeros Corporation 62225-600 N 62225-600-04

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IRRIGATIONStrengthEQ 0.3% BASE;EQ 1% BASE
Approval Date:May 30, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 8, 2020
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Jun 8, 2021
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Patent:➤ Try a Free TrialPatent Expiration:Jan 30, 2024Product Flag?Substance Flag?Delist Request?Y

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Cipla
Dow
Fuji
Merck
Daiichi Sankyo
Farmers Insurance
Chinese Patent Office
Colorcon

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