← FDA DRUG APPROVALS

FDA NDA · NDA019384

NOROXIN

Sponsor: MERCK

APPLICATION
NDA019384
TYPE
NDA
ORIGINAL APPROVAL
1986-10-31
LATEST ACTION
2016-07-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

NOROXIN · ReferenceDiscontinued
NORFLOXACIN 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2016-07-26Labeling · Supplement 67 · standardLetterAP
2013-08-14Labeling · Supplement 66 · standardLetterAP
2013-03-27Labeling · Supplement 65 · standardLetterAP
2012-06-15Labeling · Supplement 63 · standardLabelAP
2012-02-09Labeling · Supplement 62 · standardLabelAP
2011-10-18Labeling · Supplement 60 · unknownLabelAP
2011-09-16Labeling · Supplement 61 · unknownLabelAP
2011-09-08Labeling · Supplement 58LetterAP
2011-06-10Labeling · Supplement 55 · unknownLetterAP
2011-05-27Labeling · Supplement 59 · unknownLetterAP
2011-02-25Labeling · Supplement 56 · 901 requiredLetterAP
2009-04-27Labeling · Supplement 54 · standardLabelAP
2009-02-12Labeling · Supplement 53 · standardLetterAP
2008-10-03Labeling · Supplement 52 · standardLabelAP
2008-09-23Labeling · Supplement 50 · priorityLabelAP
2008-09-23Labeling · Supplement 49 · standardLetterAP
2007-03-20Manufacturing (CMC) · Supplement 47AP
2007-03-14Labeling · Supplement 48 · standardLetterAP
2006-09-22Labeling · Supplement 46 · standardLabelAP
2006-05-16Labeling · Supplement 45 · standardLabelAP
2004-07-23Labeling · Supplement 42 · standardLetterAP
2004-07-23Labeling · Supplement 40 · standardLabelAP
2004-07-23Labeling · Supplement 43 · standardLetterAP
2001-04-16Labeling · Supplement 38 · standardLetterAP
2001-04-16Labeling · Supplement 39 · standardLetterAP
2001-04-16Labeling · Supplement 37 · standardLetterAP
1998-02-09Labeling · Supplement 26 · standardAP
1997-06-20Labeling · Supplement 36 · standardReviewAP
1997-01-15Labeling · Supplement 31 · standardReviewAP
1996-12-06Manufacturing (CMC) · Supplement 35 · priorityReviewAP
1996-09-12Labeling · Supplement 29 · standardReviewAP
1996-07-18Manufacturing (CMC) · Supplement 34 · priorityReviewAP
1996-07-18Manufacturing (CMC) · Supplement 30 · priorityReviewAP
1996-06-18Manufacturing (CMC) · Supplement 32 · priorityReviewAP
1995-12-26Manufacturing (CMC) · Supplement 28 · priorityAP
1995-11-29Labeling · Supplement 27 · standardReviewAP
1994-10-24Efficacy · Supplement 20AP
1994-07-01Labeling · Supplement 24 · standardReviewAP
1993-06-29Labeling · Supplement 21AP
1992-05-06Manufacturing (CMC) · Supplement 19 · priorityAP
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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