← FDA DRUG APPROVALS

FDA NDA · NDA020799

FLOXIN OTIC

Sponsor: DAIICHI

APPLICATION
NDA020799
TYPE
NDA
ORIGINAL APPROVAL
1997-12-16
LATEST ACTION
2005-05-04
ROUTE
OTIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued

Products

FLOXIN OTIC · ReferenceDiscontinued
OFLOXACIN 0.3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION/DROPS · OTIC

Approval history

2005-05-04Labeling · Supplement 16 · standard — Label ↗AP
2004-02-24Labeling · Supplement 15 · standard — Letter ↗AP
2003-10-07Labeling · Supplement 12 · standard — Label ↗AP
2003-09-30Efficacy · Supplement 6 · standard — Letter ↗AP
2003-01-03Manufacturing (CMC) · Supplement 9 · standardAP
2002-05-07Manufacturing (CMC) · Supplement 7 · standardAP
2000-03-16Manufacturing (CMC) · Supplement 5 · standardAP
1999-12-22Manufacturing (CMC) · Supplement 4 · standardAP
1999-08-30Manufacturing (CMC) · Supplement 3 · standardAP
1999-03-16Manufacturing (CMC) · Supplement 1 · standardAP
1999-02-11Manufacturing (CMC) · Supplement 2 · standardAP
1997-12-16Type 3 - New Dosage Form · 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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