FDA NDA · NDA020485

VISINE ALLERGY EYE RELIEF MULTI-ACTION

naphazoline hydrochloride and pheniramine maleate

Sponsor: KENVUE BRANDS

APPLICATION

NDA020485

TYPE

NDA

ORIGINAL APPROVAL

1996-01-31

LATEST ACTION

2025-10-22

ROUTE

OPHTHALMIC

DOSAGE FORM

SOLUTION/DROPS

MARKETING STATUS

Over-the-counter

Products

VISINE · ReferenceOver-the-counter

NAPHAZOLINE HYDROCHLORIDE 0.025%, PHENIRAMINE MALEATE 0.3% · SOLUTION/DROPS · OPHTHALMIC

2025-10-22Manufacturing (CMC) · Supplement 21 — Letter ↗AP

2018-10-17Efficacy · Supplement 13 · standard — Letter ↗AP

2017-01-06Manufacturing (CMC) · Supplement 12 · standardAP

2016-08-26Labeling · Supplement 11 · standard — Label ↗AP

2016-03-10Manufacturing (CMC) · Supplement 10 · standardAP

2012-12-18Labeling · Supplement 9 · standard — Label ↗AP

2004-10-15Labeling · Supplement 7 · standard — Letter ↗AP

2003-09-15Manufacturing (CMC) · Supplement 6 · standard — Letter ↗AP

2002-06-14Labeling · Supplement 5 · standard — Label ↗AP

1999-03-11Manufacturing (CMC) · Supplement 4 · standardAP

1998-11-19Labeling · Supplement 3 · standardAP

1996-12-26Manufacturing (CMC) · Supplement 1 · standardAP

1996-09-26Labeling · Supplement 2 · standardAP

1996-01-31Type 5 - New Formulation or New Manufacturer · Original · standardAP

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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