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FDA ANDA · ANDA091397
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor: BAXTER HLTHCARE CORP
APPLICATION
ANDA091397
TYPE
ANDA
ORIGINAL APPROVAL
2013-08-08
LATEST ACTION
2024-09-20
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
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
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
LEVOFLOXACIN EQ 500MG/100ML (EQ 5MG/ML) · INJECTABLE · INJECTION
Approval history
2024-09-20Labeling · Supplement 24 · standardAP
2019-05-06Labeling · Supplement 18 · standardAP
2019-05-06Labeling · Supplement 19 · standardAP
2018-10-18Labeling · Supplement 16 · standardAP
2018-10-15Labeling · Supplement 15 · standardAP
2018-10-15Labeling · Supplement 9 · standardAP
2014-10-20Manufacturing (CMC) · Supplement 3AP
2014-09-23Labeling · Supplement 5 · standardAP
2014-09-23Labeling · Supplement 1 · standardAP
2013-08-08OriginalAP
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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