APPLICATION
ANDA090343
TYPE
ANDA
ORIGINAL APPROVAL
2011-07-07
LATEST ACTION
2024-09-26
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
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
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERPrescription
LEVOFLOXACIN EQ 500MG/100ML (EQ 5MG/ML) · INJECTABLE · INJECTION
Approval history
2024-09-26Labeling · Supplement 32 · standardAP
2019-05-03Labeling · Supplement 27 · standardAP
2019-04-17Labeling · Supplement 24 · standardAP
2019-04-17Labeling · Supplement 22 · standardAP
2018-10-18Labeling · Supplement 26 · standardAP
2014-11-08Labeling · Supplement 16 · standardAP
2014-11-08Labeling · Supplement 18 · standardAP
2012-11-28Labeling · Supplement 12 · standardAP
2012-03-29REMS · Supplement 6AP
2012-02-10Labeling · Supplement 4AP
2011-10-20Labeling · Supplement 1AP
2011-07-07OriginalAP
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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