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VISINE

NDA

NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE | N020485 | KENVUE BRANDS LLC

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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Lachman Consultant Services, Inc. - Citizen Petition FDA-2009-P-0557 · 3 docket documents Lachman Consultant Services, Inc. filed this citizen petition requesting that the FDA designate VISINE-A Eye Drops (naphazoline HCl 0.025%, pheniramine maleate 0.3%) as a second Reference-Listed Drug under 21 C.F.R. §314.93 to enable submission of an Abbreviated New Drug Application for a generic ve	505(q)	2009-11-19	Withdrawn	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

6 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.025%;0.3%

RLD

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Jan 31, 1996

No patent or exclusivity listings for this strength.