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FDA NDA · NDA022305

PUR-WASH

water

Sponsor: NIAGARA PHARMS

APPLICATION
NDA022305
TYPE
NDA
ORIGINAL APPROVAL
2011-09-01
LATEST ACTION
2026-02-02
ROUTE
OPHTHALMIC, IRRIGATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Over-the-counter

Products

PUR-WASH · ReferenceOver-the-counter
PURIFIED WATER 98.3% · SOLUTION · OPHTHALMIC

Approval history

2026-02-02Labeling · Supplement 8 · standard — Label ↗AP
2025-06-26Labeling · Supplement 7 · standard — Letter ↗AP
2019-12-12Labeling · Supplement 6 · standardAP
2015-01-07Manufacturing (CMC) · Supplement 4 · standardAP
2013-09-26Manufacturing (CMC) · Supplement 1 · standardAP
2011-09-01Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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