APPLICATION
BLA017837
TYPE
BLA
ORIGINAL APPROVAL
1976-02-23
LATEST ACTION
2023-08-25
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription
Products
MEGATOPEDiscontinued
ALBUMIN IODINATED I-131 SERUM 20uCi/AMP · INJECTABLE · INJECTION
MEGATOPEDiscontinued
ALBUMIN IODINATED I-131 SERUM 2mCi/VIAL · INJECTABLE · INJECTION
MEGATOPEPrescription
ALBUMIN IODINATED I-131 SERUM 0.5mCi/VIAL · INJECTABLE · INJECTION
MEGATOPEDiscontinued
ALBUMIN IODINATED I-131 SERUM 5uCi/AMP · INJECTABLE · INJECTION
MEGATOPEPrescription
ALBUMIN IODINATED I-131 SERUM 1mCi/VIAL · INJECTABLE · INJECTION
Approval history
1996-05-21Manufacturing (CMC) · Supplement 15 · standardAP
1985-09-30Manufacturing (CMC) · Supplement 13 · standardAP
1985-01-22Labeling · Supplement 12AP
1983-10-25Labeling · Supplement 10AP
1983-10-04Manufacturing (CMC) · Supplement 11 · standardAP
1981-08-17Manufacturing (CMC) · Supplement 9 · standardAP
1978-11-16Labeling · Supplement 6AP
1977-10-14Manufacturing (CMC) · Supplement 4 · standardAP
1977-10-14Labeling · Supplement 2AP
1977-10-14Labeling · Supplement 5AP
1977-10-14Labeling · Supplement 3AP
1977-10-14Labeling · Supplement 1AP
1976-02-23Type 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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