APPLICATION
NDA006459
TYPE
NDA
ORIGINAL APPROVAL
1950-11-13
LATEST ACTION
1991-05-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
HETRAZANDiscontinued
DIETHYLCARBAMAZINE CITRATE 50MG · TABLET · ORAL
Approval history
1991-05-10Manufacturing (CMC) · Supplement 7AP
1991-02-28Manufacturing (CMC) · Supplement 6AP
1985-06-07Manufacturing (CMC) · Supplement 4AP
1985-06-07Labeling · Supplement 2AP
1985-06-07Manufacturing (CMC) · Supplement 5AP
1985-06-07Manufacturing (CMC) · Supplement 3AP
1950-11-13UNKNOWN · Original · unknownAP
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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