APPLICATION
NDA011529
TYPE
NDA
ORIGINAL APPROVAL
1958-08-15
LATEST ACTION
2002-06-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PARAFON FORTE DSC · ReferenceDiscontinued
CHLORZOXAZONE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2000-12-01Manufacturing (CMC) · Supplement 53 · standardAP
2000-07-27Manufacturing (CMC) · Supplement 52 · standardAP
2000-06-13Manufacturing (CMC) · Supplement 51 · standardAP
1996-03-04Manufacturing (CMC) · Supplement 50 · standardAP
1994-12-19Labeling · Supplement 49 · standardAP
1993-01-28Manufacturing (CMC) · Supplement 47 · standardAP
1992-09-28Manufacturing (CMC) · Supplement 45 · standardAP
1992-06-10Labeling · Supplement 41 · standardAP
1991-12-16Manufacturing (CMC) · Supplement 46 · standardAP
1989-12-18Manufacturing (CMC) · Supplement 44 · standardAP
1987-06-15Manufacturing (CMC) · Supplement 36 · standardAP
1986-08-25Manufacturing (CMC) · Supplement 32 · standardAP
1986-02-20Manufacturing (CMC) · Supplement 28 · standardAP
1985-07-15Manufacturing (CMC) · Supplement 29 · standardAP
1984-05-29Manufacturing (CMC) · Supplement 27 · standardAP
1983-07-27Manufacturing (CMC) · Supplement 26 · standardAP
1983-06-16Manufacturing (CMC) · Supplement 25 · standardAP
1983-03-29Manufacturing (CMC) · Supplement 23 · standardAP
1983-03-29Manufacturing (CMC) · Supplement 21 · standardAP
1983-03-29Manufacturing (CMC) · Supplement 22 · standardAP
1981-10-27Labeling · Supplement 17 · standardAP
1977-04-29Manufacturing (CMC) · Supplement 12 · standardAP
1976-08-23Labeling · Supplement 11 · standardAP
1958-08-15Type 4 - New Combination · 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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