← FDA DRUG APPROVALS

FDA NDA · NDA019735

FLOXIN

Sponsor: JANSSEN PHARMS

APPLICATION
NDA019735
TYPE
NDA
ORIGINAL APPROVAL
1990-12-28
LATEST ACTION
2011-02-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

FLOXIN · ReferenceDiscontinued
OFLOXACIN 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
FLOXIN · ReferenceDiscontinued
OFLOXACIN 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
FLOXIN · ReferenceDiscontinued
OFLOXACIN 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2011-02-25Labeling · Supplement 61 · standard — Medication Guide ↗AP
2009-02-12Labeling · Supplement 60 · standard — Letter ↗AP
2008-10-03Labeling · Supplement 59 · standard — Letter ↗AP
2007-12-13Labeling · Supplement 58 · standard — Letter ↗AP
2007-06-19Labeling · Supplement 57 · standard — Letter ↗AP
2007-05-16Labeling · Supplement 56 · standard — Label ↗AP
2006-06-14Labeling · Supplement 55 · standard — Letter ↗AP
2006-01-20Labeling · Supplement 54 · standard — Label ↗AP
2004-09-15Labeling · Supplement 53 · standard — Review ↗AP
2004-09-15Labeling · Supplement 52 · standard — Letter ↗AP
2004-03-06Labeling · Supplement 51 · standard — Letter ↗AP
2000-10-30Manufacturing (CMC) · Supplement 50 · standardAP
1999-12-08Labeling · Supplement 45 · standardAP
1999-12-08Labeling · Supplement 49 · standardAP
1999-12-08Labeling · Supplement 47 · standardAP
1999-09-08Manufacturing (CMC) · Supplement 48 · standardAP
1999-03-25Manufacturing (CMC) · Supplement 46 · standardAP
1998-09-21Labeling · Supplement 44 · standardAP
1997-08-11Labeling · Supplement 39 · standardAP
1996-12-19Efficacy · Supplement 42 · standardAP
1996-09-11Labeling · Supplement 38 · standardAP
1996-06-28Manufacturing (CMC) · Supplement 43 · standardAP
1995-11-09Manufacturing (CMC) · Supplement 41 · standardAP
1995-09-22Manufacturing (CMC) · Supplement 40 · standardAP
1995-01-09Manufacturing (CMC) · Supplement 35 · standardAP
1994-08-08Manufacturing (CMC) · Supplement 36 · standardAP
1994-07-21Labeling · Supplement 24 · standardAP
1993-12-07Manufacturing (CMC) · Supplement 34 · standardAP
1993-11-30Manufacturing (CMC) · Supplement 31 · standardAP
1993-11-30Manufacturing (CMC) · Supplement 32 · standardAP
1993-11-30Manufacturing (CMC) · Supplement 30 · standardAP
1993-09-20Manufacturing (CMC) · Supplement 15 · standardAP
1993-08-11Manufacturing (CMC) · Supplement 21 · standardAP
1992-12-08Manufacturing (CMC) · Supplement 18 · standard — Review ↗AP
1992-09-10Manufacturing (CMC) · Supplement 19 · standard — Review ↗AP
1992-09-03Manufacturing (CMC) · Supplement 23 · standard — Review ↗AP
1992-09-03Manufacturing (CMC) · Supplement 22 · standard — Review ↗AP
1992-07-14Manufacturing (CMC) · Supplement 16 · standard — Review ↗AP
1992-06-23Manufacturing (CMC) · Supplement 8 · standard — Review ↗AP
1992-05-15Manufacturing (CMC) · Supplement 7 · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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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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