APPLICATION
NDA018067
TYPE
NDA
ORIGINAL APPROVAL
1980-06-13
LATEST ACTION
2007-12-07
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
CINOBACDiscontinued
CINOXACIN 500MG · CAPSULE · ORAL
CINOBACDiscontinued
CINOXACIN 250MG · CAPSULE · ORAL
Approval history
2007-12-07Labeling · Supplement 16AP
2007-12-07Labeling · Supplement 8AP
2007-12-07Labeling · Supplement 7AP
2000-08-24Manufacturing (CMC) · Supplement 31 · standardAP
2000-01-21Manufacturing (CMC) · Supplement 30 · standardAP
1998-08-04Manufacturing (CMC) · Supplement 27 · standardAP
1998-08-04Manufacturing (CMC) · Supplement 28 · standardAP
1998-02-13Manufacturing (CMC) · Supplement 26 · standardAP
1996-02-21Manufacturing (CMC) · Supplement 25 · standardAP
1996-02-07Manufacturing (CMC) · Supplement 24 · standardAP
1992-08-11Labeling · Supplement 20AP
1992-08-11Labeling · Supplement 21AP
1989-08-21Labeling · Supplement 19AP
1988-12-02Manufacturing (CMC) · Supplement 17 · standardAP
1988-11-25Manufacturing (CMC) · Supplement 12 · standardAP
1987-10-28Labeling · Supplement 11AP
1987-06-18Manufacturing (CMC) · Supplement 14 · standardAP
1987-06-18Manufacturing (CMC) · Supplement 15 · standardAP
1987-05-11Labeling · Supplement 13AP
1987-04-13Labeling · Supplement 4AP
1985-11-22Labeling · Supplement 10AP
1985-10-16Labeling · Supplement 9AP
1984-05-31Manufacturing (CMC) · Supplement 5 · standardAP
1981-11-03Manufacturing (CMC) · Supplement 3 · standardAP
1981-01-13Manufacturing (CMC) · Supplement 2 · standardAP
1980-08-14Manufacturing (CMC) · Supplement 1 · standardAP
1980-06-13Type 1 - New Molecular Entity · 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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