APPLICATION
NDA017535
TYPE
NDA
ORIGINAL APPROVAL
1977-02-01
LATEST ACTION
1991-08-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
LORELCODiscontinued
PROBUCOL 250MG · TABLET · ORAL
LORELCODiscontinued
PROBUCOL 500MG · TABLET · ORAL
Approval history
1991-08-26Manufacturing (CMC) · Supplement 46 · priorityAP
1989-05-09Manufacturing (CMC) · Supplement 45 · priorityAP
1989-05-05Manufacturing (CMC) · Supplement 42 · priorityAP
1989-05-05Manufacturing (CMC) · Supplement 43 · priorityAP
1988-07-06Labeling · Supplement 40 · priorityAP
1988-07-06Manufacturing (CMC) · Supplement 41 · priorityAP
1988-03-31Manufacturing (CMC) · Supplement 37 · priorityAP
1988-01-22Manufacturing (CMC) · Supplement 38 · priorityAP
1986-02-25Labeling · Supplement 36 · priorityAP
1984-08-02Manufacturing (CMC) · Supplement 33 · priorityAP
1984-05-01Manufacturing (CMC) · Supplement 30 · priorityAP
1984-04-12Labeling · Supplement 31 · priorityAP
1983-11-18Manufacturing (CMC) · Supplement 29 · priorityAP
1983-09-07Labeling · Supplement 28 · priorityAP
1981-12-02Manufacturing (CMC) · Supplement 23 · priorityAP
1981-10-22Manufacturing (CMC) · Supplement 22 · priorityAP
1980-06-23Manufacturing (CMC) · Supplement 17 · priorityAP
1979-04-12Labeling · Supplement 6 · priorityAP
1979-04-12Labeling · Supplement 1 · priorityAP
1978-03-13Manufacturing (CMC) · Supplement 8 · priorityAP
1977-02-01Type 1 - New Molecular Entity · Original · priorityAP
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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