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FDA NDA · NDA019857
CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor: BAYER HLTHCARE
APPLICATION
NDA019857
TYPE
NDA
ORIGINAL APPROVAL
1990-12-26
LATEST ACTION
2022-03-25
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER · ReferenceDiscontinued
CIPROFLOXACIN 400MG/200ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER · ReferenceDiscontinued
CIPROFLOXACIN 200MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2013-10-14Manufacturing (CMC) · Supplement 61 · standardAP
2002-12-10Manufacturing (CMC) · Supplement 29 · standardAP
2000-06-28Labeling · Supplement 25 · standardAP
1999-06-09Manufacturing (CMC) · Supplement 26 · standardAP
1999-01-07Manufacturing (CMC) · Supplement 23 · standardAP
1998-11-13Manufacturing (CMC) · Supplement 22 · standardAP
1998-09-24Efficacy · Supplement 19 · standardAP
1998-09-24Efficacy · Supplement 21 · standardAP
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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