APPLICATION
ANDA077782
TYPE
ANDA
ORIGINAL APPROVAL
2006-08-28
LATEST ACTION
2024-09-20
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
CIPROFLOXACINDiscontinued
CIPROFLOXACIN 200MG/20ML (10MG/ML) · INJECTABLE · INJECTION
CIPROFLOXACINDiscontinued
CIPROFLOXACIN 400MG/40ML (10MG/ML) · INJECTABLE · INJECTION
Approval history
2024-09-20Labeling · Supplement 21 · standardAP
2019-05-03Labeling · Supplement 20 · standardAP
2019-04-26Labeling · Supplement 19 · standardAP
2019-04-26Labeling · Supplement 18 · standardAP
2019-04-26Labeling · Supplement 16 · standardAP
2018-10-18Labeling · Supplement 17 · standardAP
2014-06-30Labeling · Supplement 15 · standardAP
2011-06-23Labeling · Supplement 8AP
2009-10-05Labeling · Supplement 3AP
2009-01-29Labeling · Supplement 2AP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.