APPLICATION
NDA012383
TYPE
NDA
ORIGINAL APPROVAL
1961-07-27
LATEST ACTION
1994-08-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
COLBENEMID · ReferenceDiscontinued
COLCHICINE 0.5MG, PROBENECID 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
1994-08-18Manufacturing (CMC) · Supplement 28 · standardAP
1994-04-20Manufacturing (CMC) · Supplement 27 · standardAP
1989-11-30Manufacturing (CMC) · Supplement 26 · standardAP
1988-05-12Labeling · Supplement 24 · standardAP
1988-05-12Labeling · Supplement 23 · standardAP
1988-05-12Labeling · Supplement 21 · standardAP
1985-07-23Manufacturing (CMC) · Supplement 18 · standardAP
1982-03-02Manufacturing (CMC) · Supplement 20 · standardAP
1981-08-21Labeling · Supplement 14 · standardAP
1979-08-24Labeling · Supplement 16 · standardAP
1979-05-30Manufacturing (CMC) · Supplement 12 · standardAP
1979-05-10Manufacturing (CMC) · Supplement 15 · standardAP
1978-06-01Labeling · Supplement 13 · standardAP
1961-07-27Type 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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