← FDA DRUG APPROVALS

FDA NDA · NDA021473

CIPRO XR

Sponsor: BAYER HLTHCARE

APPLICATION
NDA021473
TYPE
NDA
ORIGINAL APPROVAL
2002-12-13
LATEST ACTION
2021-03-30
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

CIPRO XRDiscontinued
CIPROFLOXACIN 212.6MG, CIPROFLOXACIN HYDROCHLORIDE EQ 287.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
CIPRO XRDiscontinued
CIPROFLOXACIN 425.2MG, CIPROFLOXACIN HYDROCHLORIDE EQ 574.9MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL

Approval history

2021-03-30Labeling · Supplement 43 · standard — Letter ↗AP
2020-05-08Labeling · Supplement 42 · standard — Letter ↗AP
2020-03-05Labeling · Supplement 41 · standard — Label ↗AP
2019-05-03Labeling · Supplement 40 · standard — Letter ↗AP
2018-10-18Labeling · Supplement 39 · standard — Label ↗AP
2017-07-26Labeling · Supplement 38 · standard — Label ↗AP
2016-07-26Labeling · Supplement 37 · standard — Letter ↗AP
2015-01-30Labeling · Supplement 36 · standard — Label ↗AP
2013-08-14Labeling · Supplement 35 · 901 required — Label ↗AP
2013-01-30Labeling · Supplement 34 · standard — Label ↗AP
2011-11-15Labeling · Supplement 27 · standard — Letter ↗AP
2011-10-18Labeling · Supplement 33 · unknown — Label ↗AP
2011-08-03REMS · Supplement 32 — Letter ↗AP
2011-06-10Labeling · Supplement 31 · standard — Letter ↗AP
2011-02-25Labeling · Supplement 28 · 901 required — Label ↗AP
2009-06-24Labeling · Supplement 26 · standard — Letter ↗AP
2009-04-27Labeling · Supplement 25 · standard — Letter ↗AP
2008-10-03Labeling · Supplement 24 · standard — Letter ↗AP
2008-01-18Labeling · Supplement 23 · standard — Letter ↗AP
2007-06-25Labeling · Supplement 22 · standard — Letter ↗AP
2006-06-19Labeling · Supplement 16 · standardAP
2005-11-09Labeling · Supplement 13 · standard — Review ↗AP
2005-05-18Labeling · Supplement 9 · standard — Label ↗AP
2004-07-14Labeling · Supplement 7 · standard — Label ↗AP
2004-07-14Labeling · Supplement 5 · standard — Review ↗AP
2004-07-14Labeling · Supplement 6 · standard — Letter ↗AP
2002-12-13Type 3 - New Dosage Form · Original · 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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