APPLICATION
NDA020759
TYPE
NDA
ORIGINAL APPROVAL
1997-12-18
LATEST ACTION
2000-05-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TROVANDiscontinued
TROVAFLOXACIN MESYLATE EQ 200MG BASE · TABLET · ORAL
TROVANDiscontinued
TROVAFLOXACIN MESYLATE EQ 100MG BASE · TABLET · ORAL
Approval history
2000-05-17Labeling · Supplement 8 · standardAP
2000-05-17Labeling · Supplement 6 · standardAP
2000-05-17Labeling · Supplement 4 · standardAP
2000-05-17Labeling · Supplement 7 · standardAP
1999-04-15Manufacturing (CMC) · Supplement 5 · standardAP
1999-03-19Manufacturing (CMC) · Supplement 3 · standardAP
1999-02-17Manufacturing (CMC) · Supplement 2 · standardAP
1998-09-23Labeling · Supplement 1 · 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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