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OCUFEN

NDA

FLURBIPROFEN SODIUM | N019404 | ALLERGAN PHARMACEUTICAL

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain1 active DMF1 inactive

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

SHANGHAI WONDER PHARMACEUTICAL CO LTDFLURBIPROFEN SODIUM

DMF 397002024

WYCKOFF CHEMICAL CO INCInactiveFLURBIPROFEN SODIUM

DMF 102481993

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jul 30, 2012	SUPPL -26	View Letter (PDF)
Jun 10, 2004	SUPPL -20	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.03% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Dec 31, 1986

No patent or exclusivity listings for this strength.