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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 six 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 NDA: 205388

Tradename:
OMIDRIA
Applicant:
Omeros
Ingredient:
ketorolac tromethamine; phenylephrine hydrochloride
Patents:6
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 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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IRRIGATIONStrengthEQ 0.3% BASE;EQ 1% BASE
Approval Date:May 30, 2014TE:RLD:Yes
Patent:8,586,633Patent Expiration:Jul 30, 2023Product Flag?YSubstance Flag?Delist Request?
Patent:9,066,856Patent Expiration:Oct 23, 2033Product Flag?YSubstance Flag?Delist Request?
Patent:9,399,040Patent Expiration:Jul 30, 2023Product Flag?YSubstance Flag?Delist Request?


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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