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FDA ANDA · ANDA216164
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor: KNACK
APPLICATION
ANDA216164
TYPE
ANDA
ORIGINAL APPROVAL
2024-01-29
LATEST ACTION
2024-09-20
ROUTE
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 1 · standardAP
2024-01-29UNKNOWN · 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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