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FDA NDA · NDA020226
NAPHCON A
naphazoline hydrochloride and pheniramine maleate
Sponsor: ALCON
APPLICATION
NDA020226
TYPE
NDA
ORIGINAL APPROVAL
1994-06-08
LATEST ACTION
2022-12-19
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Over-the-counter
Products
NAPHCON-A · ReferenceOver-the-counter
NAPHAZOLINE HYDROCHLORIDE 0.025%, PHENIRAMINE MALEATE 0.3% · SOLUTION/DROPS · OPHTHALMIC
Approval history
2015-07-31Manufacturing (CMC) · Supplement 24 · standardAP
2014-06-23Manufacturing (CMC) · Supplement 22 · standardAP
2002-12-04Manufacturing (CMC) · Supplement 18 · standardAP
2001-03-16Manufacturing (CMC) · Supplement 17 · standardAP
2000-09-22Manufacturing (CMC) · Supplement 16 · standardAP
2000-03-17Manufacturing (CMC) · Supplement 15 · standardAP
2000-01-21Manufacturing (CMC) · Supplement 14 · standardAP
1999-12-16Manufacturing (CMC) · Supplement 10 · standardAP
1999-11-19Manufacturing (CMC) · Supplement 13 · standardAP
1999-10-04Manufacturing (CMC) · Supplement 12 · standardAP
1999-06-14Manufacturing (CMC) · Supplement 11 · standardAP
1998-08-20Manufacturing (CMC) · Supplement 9 · standardAP
1997-12-23Manufacturing (CMC) · Supplement 8 · standardAP
1996-09-26Labeling · Supplement 7 · standardAP
1996-07-30Labeling · Supplement 5 · standardAP
1996-04-16Manufacturing (CMC) · Supplement 6 · standardAP
1995-11-01Manufacturing (CMC) · Supplement 4 · standardAP
1995-11-01Manufacturing (CMC) · Supplement 3 · standardAP
1995-02-23Labeling · Supplement 2 · standardAP
1994-10-04Labeling · Supplement 1 · standardAP
1994-06-08Type 4 - New Combination · 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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