APPLICATION
ANDA205833
TYPE
ANDA
ORIGINAL APPROVAL
2017-05-05
LATEST ACTION
2023-05-19
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINERPrescription
MOXIFLOXACIN HYDROCHLORIDE 400MG/250ML (1.6MG/ML) · SOLUTION · INTRAVENOUS
Approval history
2023-05-19Labeling · Supplement 9 · standardAP
2019-12-04Labeling · Supplement 8 · standardAP
2019-05-03Labeling · Supplement 5 · standardAP
2019-04-30Labeling · Supplement 6 · standardAP
2018-10-18Labeling · Supplement 3 · standardAP
2017-05-05UNKNOWN · 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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