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FDA NDA · NDA019847

CIPRO

Sponsor: BAYER HLTHCARE

APPLICATION
NDA019847
TYPE
NDA
ORIGINAL APPROVAL
1990-12-26
LATEST ACTION
2024-09-20
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

CIPRODiscontinued
CIPROFLOXACIN 1200MG/120ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
CIPRO · ReferenceDiscontinued
CIPROFLOXACIN 400MG/40ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
CIPRO · ReferenceDiscontinued
CIPROFLOXACIN 200MG/20ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2024-09-20Labeling · Supplement 64 · standardLetterAP
2022-03-25Labeling · Supplement 63 · standardLabelAP
2020-05-08Labeling · Supplement 62 · standardLetterAP
2020-03-05Labeling · Supplement 61 · standardLetterAP
2019-05-03Labeling · Supplement 60 · standardLetterAP
2018-10-18Labeling · Supplement 59 · standardLetterAP
2017-07-28Labeling · Supplement 58 · standardLabelAP
2016-07-26Labeling · Supplement 57 · standardLetterAP
2015-03-19Labeling · Supplement 56 · standardLabelAP
2015-02-02Efficacy · Supplement 55 · standardLabelAP
2013-08-14Labeling · Supplement 54 · 901 requiredLetterAP
2013-01-30Labeling · Supplement 53 · standardLetterAP
2011-11-15Labeling · Supplement 46 · standardLetterAP
2011-10-18Labeling · Supplement 52 · unknownLabelAP
2011-08-12Labeling · Supplement 50 · unknownLabelAP
2011-08-03REMS · Supplement 51LetterAP
2011-02-25Labeling · Supplement 47 · 901 requiredLabelAP
2009-06-24Labeling · Supplement 45 · standardLetterAP
2009-04-27Labeling · Supplement 44 · standardLetterAP
2009-02-13Labeling · Supplement 43 · standardLabelAP
2008-10-03Labeling · Supplement 42 · standardLetterAP
2008-01-18Labeling · Supplement 41 · standardLetterAP
2007-06-25Labeling · Supplement 39 · standardLetterAP
2006-06-19Labeling · Supplement 37 · standardLetterAP
2005-11-09Labeling · Supplement 36 · standardLabelAP
2005-05-18Labeling · Supplement 32 · standardLetterAP
2005-01-07Efficacy · Supplement 30 · unknownLabelAP
2004-07-14Labeling · Supplement 29 · standardLabelAP
2004-07-14Labeling · Supplement 31 · standardReviewAP
2004-07-14Labeling · Supplement 28 · standardLetterAP
2004-03-25Efficacy · Supplement 27 · priorityReviewAP
2002-04-17Labeling · Supplement 26LetterAP
2000-10-31Manufacturing (CMC) · Supplement 25 · standardAP
2000-08-30Efficacy · Supplement 24 · priorityLetterAP
2000-06-28Labeling · Supplement 21 · standardAP
1999-11-01Manufacturing (CMC) · Supplement 22 · standardReviewAP
1998-09-24Labeling · Supplement 20 · standardAP
1998-09-24Labeling · Supplement 17 · standardAP
1998-09-24Efficacy · Supplement 18 · standardAP
1998-09-24Efficacy · Supplement 16 · 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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