APPLICATION
NDA012366
TYPE
NDA
ORIGINAL APPROVAL
1960-10-05
LATEST ACTION
2013-05-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
SOMA COMPOUND W/ CODEINEDiscontinued
ASPIRIN 325MG, CARISOPRODOL 200MG, CODEINE PHOSPHATE 16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2001-06-22Manufacturing (CMC) · Supplement 28 · standardAP
2000-03-02Manufacturing (CMC) · Supplement 29 · standardAP
1998-04-15Manufacturing (CMC) · Supplement 26 · standardAP
1993-10-22Manufacturing (CMC) · Supplement 25 · standardAP
1986-01-16Labeling · Supplement 21 · standardAP
1984-02-23Manufacturing (CMC) · Supplement 19 · standardAP
1983-07-11Manufacturing (CMC) · Supplement 18 · standardAP
1983-04-19Manufacturing (CMC) · Supplement 17 · standardAP
1983-04-05Manufacturing (CMC) · Supplement 15 · standardAP
1983-04-05Manufacturing (CMC) · Supplement 16 · standardAP
1982-02-23Labeling · Supplement 13 · standardAP
1981-11-16Manufacturing (CMC) · Supplement 10 · standardAP
1981-11-16Labeling · Supplement 9 · standardAP
1981-10-29Manufacturing (CMC) · Supplement 12 · standardAP
1974-07-19Labeling · Supplement 6 · standardAP
1960-10-05Type 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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