APPLICATION
NDA006800
TYPE
NDA
ORIGINAL APPROVAL
1949-06-15
LATEST ACTION
1989-03-24
ROUTE
ORAL
DOSAGE FORM
SOLUTION, CAPSULE
MARKETING STATUS
Discontinued
Products
PARADIONEDiscontinued
PARAMETHADIONE 300MG/ML · SOLUTION · ORAL
PARADIONEDiscontinued
PARAMETHADIONE 150MG · CAPSULE · ORAL
PARADIONEDiscontinued
PARAMETHADIONE 300MG · CAPSULE · ORAL
Approval history
1989-03-24Manufacturing (CMC) · Supplement 15AP
1987-12-02Manufacturing (CMC) · Supplement 14AP
1984-12-07Manufacturing (CMC) · Supplement 13AP
1982-06-28Manufacturing (CMC) · Supplement 12AP
1980-07-14Labeling · Supplement 10AP
1979-10-24Manufacturing (CMC) · Supplement 8AP
1975-07-29Manufacturing (CMC) · Supplement 5AP
1949-06-15OriginalAP
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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