APPLICATION
BLA017833
TYPE
BLA
ORIGINAL APPROVAL
1976-02-23
LATEST ACTION
2001-05-01
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
MACROTECDiscontinued
TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT N/A · INJECTABLE · INJECTION
Approval history
2001-05-01Manufacturing (CMC) · Supplement 12 · standardAP
1994-03-21Manufacturing (CMC) · Supplement 11 · standardAP
1989-10-06Labeling · Supplement 10AP
1985-09-30Manufacturing (CMC) · Supplement 8 · standardAP
1984-07-06Labeling · Supplement 7AP
1978-06-12Labeling · Supplement 4AP
1977-07-13Labeling · Supplement 3AP
1977-07-13Labeling · Supplement 1AP
1977-04-25Labeling · Supplement 2AP
1976-02-23Type 2 - New Active Ingredient · 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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