APPLICATION
NDA005545
TYPE
NDA
ORIGINAL APPROVAL
1944-07-31
LATEST ACTION
1998-04-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
DICUMAROLDiscontinued
DICUMAROL 50MG · TABLET · ORAL
DICUMAROLDiscontinued
DICUMAROL 100MG · TABLET · ORAL
DICUMAROLDiscontinued
DICUMAROL 25MG · TABLET · ORAL
Approval history
1998-04-14Manufacturing (CMC) · Supplement 18AP
1987-02-25Labeling · Supplement 17AP
1986-08-14Manufacturing (CMC) · Supplement 16AP
1985-08-26Manufacturing (CMC) · Supplement 15AP
1982-12-01Labeling · Supplement 14AP
1982-08-10Labeling · Supplement 13AP
1982-06-10Manufacturing (CMC) · Supplement 9AP
1982-06-10Manufacturing (CMC) · Supplement 10AP
1977-03-23Labeling · Supplement 8AP
1975-12-18Labeling · Supplement 7AP
1944-07-31OriginalAP
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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