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.

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

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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
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014	⤷ Sign Up	⤷ Sign Up
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