APPLICATION
ANDA208682
TYPE
ANDA
ORIGINAL APPROVAL
2017-09-22
LATEST ACTION
2020-06-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
MOXIFLOXACIN HYDROCHLORIDEPrescription
MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE · TABLET · ORAL
Approval history
2020-06-03Labeling · Supplement 3 · standardAP
2020-06-03Labeling · Supplement 2 · standardAP
2020-06-03Labeling · Supplement 5 · standardAP
2019-09-27Manufacturing (CMC) · Supplement 1 · standardAP
2017-09-22UNKNOWN · 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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