APPLICATION
NDA007707
TYPE
NDA
ORIGINAL APPROVAL
1951-06-28
LATEST ACTION
1983-10-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PHENURONE · ReferenceDiscontinued
PHENACEMIDE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
1983-10-28Manufacturing (CMC) · Supplement 5 · priorityAP
1983-09-07Manufacturing (CMC) · Supplement 6 · priorityAP
1982-02-17Labeling · Supplement 4 · priorityAP
1980-02-26Labeling · Supplement 3 · priorityAP
1951-06-28Type 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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