APPLICATION
NDA011467
TYPE
NDA
ORIGINAL APPROVAL
1960-05-20
LATEST ACTION
2009-03-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TRANCOPALDiscontinued
CHLORMEZANONE 200MG · TABLET · ORAL
TRANCOPALDiscontinued
CHLORMEZANONE 100MG · TABLET · ORAL
Approval history
2009-03-13Labeling · Supplement 25AP
2009-03-13Labeling · Supplement 17AP
2009-03-13Labeling · Supplement 8AP
2009-03-13Labeling · Supplement 22AP
1995-02-15Manufacturing (CMC) · Supplement 30 · standardAP
1993-09-30Manufacturing (CMC) · Supplement 28 · standardAP
1993-06-08Manufacturing (CMC) · Supplement 29 · standardAP
1993-05-25Manufacturing (CMC) · Supplement 24 · standardAP
1991-11-08Manufacturing (CMC) · Supplement 19 · standardAP
1990-07-25Manufacturing (CMC) · Supplement 27 · standardAP
1988-01-20Labeling · Supplement 23AP
1987-01-28Manufacturing (CMC) · Supplement 20 · standardAP
1985-10-29Labeling · Supplement 21AP
1984-08-29Manufacturing (CMC) · Supplement 16 · standardAP
1984-08-22Manufacturing (CMC) · Supplement 18 · standardAP
1984-01-24Manufacturing (CMC) · Supplement 15 · standardAP
1981-12-17Manufacturing (CMC) · Supplement 11 · standardAP
1981-02-10Manufacturing (CMC) · Supplement 12 · standardAP
1979-04-05Manufacturing (CMC) · Supplement 10 · standardAP
1979-04-04Labeling · Supplement 9AP
1976-12-14Manufacturing (CMC) · Supplement 6 · standardAP
1960-05-20Type 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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