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FDA NDA · NDA019858
CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Sponsor: BAYER PHARMS
APPLICATION
NDA019858
TYPE
NDA
ORIGINAL APPROVAL
1990-12-26
LATEST ACTION
2002-04-17
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDiscontinued
CIPROFLOXACIN 200MG/100ML · INJECTABLE · INJECTION
Approval history
2000-06-28Labeling · Supplement 20 · standardAP
1998-09-24Efficacy · Supplement 18 · standardAP
1998-09-24Efficacy · Supplement 16 · standardAP
1998-09-24Labeling · Supplement 19 · standardAP
1998-09-24Labeling · Supplement 17 · standardAP
1998-04-03Efficacy · Supplement 12 · standardAP
1997-08-07Efficacy · Supplement 15 · standardAP
1996-10-21Efficacy · Supplement 8 · standardAP
1996-10-10Efficacy · Supplement 9 · standardAP
1996-08-09Labeling · Supplement 14 · standardAP
1996-07-09Manufacturing (CMC) · Supplement 13 · standardAP
1995-10-25Labeling · Supplement 6 · standardAP
1992-05-13Manufacturing (CMC) · Supplement 3 · standardAP
1992-04-23Manufacturing (CMC) · Supplement 5 · standardAP
1991-04-24Manufacturing (CMC) · Supplement 1 · standardAP
1991-04-24Manufacturing (CMC) · Supplement 2 · standardAP
1990-12-26Type 3 - New Dosage Form · Original · 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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