APPLICATION
NDA016224
TYPE
NDA
ORIGINAL APPROVAL
1971-11-23
LATEST ACTION
2009-03-13
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ROBENGATOPEDiscontinued
ROSE BENGAL SODIUM I-131 2mCi/VIAL · INJECTABLE · INJECTION
ROBENGATOPEDiscontinued
ROSE BENGAL SODIUM I-131 0.5mCi/VIAL · INJECTABLE · INJECTION
ROBENGATOPEDiscontinued
ROSE BENGAL SODIUM I-131 1mCi/VIAL · INJECTABLE · INJECTION
Approval history
2009-03-13Labeling · Supplement 13AP
1982-06-11Manufacturing (CMC) · Supplement 11 · priorityAP
1976-12-07Manufacturing (CMC) · Supplement 5 · priorityAP
1976-12-01Labeling · Supplement 4AP
1971-11-23Type 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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