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FDA ANDA · ANDA206919
LEVOFLOXACIN
levofloxacin in 5% dextrose
Sponsor: EUGIA PHARMA
APPLICATION
ANDA206919
TYPE
ANDA
ORIGINAL APPROVAL
2016-02-10
LATEST ACTION
2024-09-20
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
LEVOFLOXACIN EQ 500MG/100ML (EQ 5MG/ML) · INJECTABLE · INJECTION
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
LEVOFLOXACIN EQ 750MG/150ML (EQ 5MG/ML) · INJECTABLE · INJECTION
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
LEVOFLOXACIN EQ 250MG/50ML (EQ 5MG/ML) · INJECTABLE · INJECTION
Approval history
2024-09-20Labeling · Supplement 9 · standardAP
2019-05-03Labeling · Supplement 5 · standardAP
2018-10-18Labeling · Supplement 4 · standardAP
2018-10-15Labeling · Supplement 2 · standardAP
2018-10-15Labeling · Supplement 3 · standardAP
2016-02-10UNKNOWN · 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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