APPLICATION
NDA015419
TYPE
NDA
ORIGINAL APPROVAL
1970-06-25
LATEST ACTION
2009-03-13
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
HIPPUTOPEDiscontinued
IODOHIPPURATE SODIUM I-131 1-2mCi/VIAL · INJECTABLE · INJECTION
Approval history
2009-03-13Labeling · Supplement 7AP
2009-03-13Labeling · Supplement 8AP
1985-09-30Manufacturing (CMC) · Supplement 14 · standardAP
1985-06-12Labeling · Supplement 12AP
1983-06-08Manufacturing (CMC) · Supplement 9 · standardAP
1970-06-25Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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