APPLICATION
NDA017047
TYPE
NDA
ORIGINAL APPROVAL
1973-05-07
LATEST ACTION
1984-10-25
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
SETHOTOPEDiscontinued
SELENOMETHIONINE SE-75 85-550uCi/ML · INJECTABLE · INJECTION
Approval history
1984-10-25Labeling · Supplement 12AP
1983-04-20Manufacturing (CMC) · Supplement 13 · priorityAP
1983-04-20Manufacturing (CMC) · Supplement 14 · priorityAP
1982-05-21Labeling · Supplement 11AP
1978-05-23Manufacturing (CMC) · Supplement 9 · priorityAP
1977-12-21Labeling · Supplement 8AP
1977-12-21Labeling · Supplement 5AP
1977-07-19Labeling · Supplement 6AP
1976-10-08Manufacturing (CMC) · Supplement 4 · priorityAP
1976-06-11Labeling · Supplement 2AP
1976-05-24Manufacturing (CMC) · Supplement 3 · priorityAP
1973-05-07Type 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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