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FDA NDA · NDA020065

EYE ALLERGY RELIEF

pheniramine maleate and naphazoline hydrochloride

Sponsor: BAUSCH AND LOMB

APPLICATION
NDA020065
TYPE
NDA
ORIGINAL APPROVAL
1994-06-08
LATEST ACTION
2022-09-23
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Over-the-counter

Products

OPCON-A · ReferenceOver-the-counter
NAPHAZOLINE HYDROCHLORIDE 0.02675%, PHENIRAMINE MALEATE 0.315% · SOLUTION/DROPS · OPHTHALMIC

Approval history

2022-09-23Labeling · Supplement 33 · standard — Letter ↗AP
2016-03-14Manufacturing (CMC) · Supplement 22 · standardAP
2015-09-18Manufacturing (CMC) · Supplement 21 · standardAP
2015-05-12Manufacturing (CMC) · Supplement 20 · standardAP
2007-07-31Labeling · Supplement 17 · standard — Label ↗AP
2005-04-20Manufacturing (CMC) · Supplement 10 · standard — Letter ↗AP
1996-12-18Manufacturing (CMC) · Supplement 15 · standardAP
1996-07-23Labeling · Supplement 14 · standardAP
1996-07-23Labeling · Supplement 13 · standardAP
1996-05-09Labeling · Supplement 11 · standardAP
1996-04-11Manufacturing (CMC) · Supplement 8 · standardAP
1996-03-13Manufacturing (CMC) · Supplement 9 · standardAP
1995-05-11Manufacturing (CMC) · Supplement 5 · standardAP
1994-11-29Manufacturing (CMC) · Supplement 2 · standardAP
1994-11-29Manufacturing (CMC) · Supplement 3 · standardAP
1994-10-11Manufacturing (CMC) · Supplement 1 · standardAP
1994-06-08Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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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