APPLICATION
ANDA091375
TYPE
ANDA
ORIGINAL APPROVAL
2011-09-16
LATEST ACTION
2024-09-20
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERPrescription
LEVOFLOXACIN EQ 500MG/100ML (EQ 5MG/ML) · INJECTABLE · INJECTION
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERPrescription
LEVOFLOXACIN EQ 750MG/150ML (EQ 5MG/ML) · INJECTABLE · INJECTION
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERPrescription
LEVOFLOXACIN EQ 250MG/50ML (EQ 5MG/ML) · INJECTABLE · INJECTION
Approval history
2024-09-20Labeling · Supplement 23 · standardAP
2019-05-03Labeling · Supplement 15 · standardAP
2019-04-15Labeling · Supplement 12 · standardAP
2019-04-15Labeling · Supplement 9 · standardAP
2018-10-18Labeling · Supplement 14 · standardAP
2016-01-04Labeling · Supplement 5 · standardAP
2013-11-05Labeling · Supplement 4 · standardAP
2012-07-25REMS · Supplement 2AP
2012-02-10Labeling · Supplement 1AP
2011-09-16Not Applicable · OriginalAP
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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