FDA ANDA · ANDA205348
MOXIFLOXACIN HYDROCHLORIDE
Sponsor: CROSSMEDIKA SA
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APPLICATION
ANDA205348
TYPE
ANDA
ORIGINAL APPROVAL
2016-01-14
LATEST ACTION
2026-10-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
MOXIFLOXACIN HYDROCHLORIDEPrescription
MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE · TABLET · ORAL
Approval history
2026-10-05Labeling · Supplement 8 · standardAP
2025-04-14Labeling · Supplement 6 · standardAP
2020-02-07Labeling · Supplement 1 · standardAP
2020-02-07Labeling · Supplement 4 · standardAP
2020-02-07Labeling · Supplement 2 · standardAP
2016-01-14UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →