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PUR-WASH

NDA

PURIFIED WATER | N022305 | NIAGARA PHARMACEUTICALS INC

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

1 trial from ClinicalTrials.gov, 1 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
Xylitol BSI Multisite - Reduction of Bloodstream Infections From Oral Organisms in Pediatric Stem Cell Transplant NCT05579639	Phase 2	Active	Children's Hospital Medical Center, Cincinnati	256	2023-04-04 → 2026-09-11

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jun 27, 2025	SUPPL -7	View Letter (PDF)
Sep 16, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 98.3%

RLD

0 patents0 exclusivities▴

SOLUTION;OPHTHALMIC | Approved: Sep 1, 2011

No patent or exclusivity listings for this strength.