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KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE

ANDA

KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE | A210183 | LUPIN LTD

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: OMIDRIA(TE code: AT)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
OMEROS CORPORATION v. LUPIN LTD et al 3:2017cv04595 6 patentsANDA 210183phenylephrine hydrochloride and ketorolac tromethamine	D.N.J.	2017-06-22	Terminated 2017-10-13	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 7, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.3% BASE;EQ 1% BASE

0 patents0 exclusivities▴

SOLUTION;IRRIGATION | Approved: Jul 1, 2019

No patent or exclusivity listings for this strength.