APPLICATION
BLA017776
TYPE
BLA
ORIGINAL APPROVAL
1976-11-16
LATEST ACTION
2002-07-30
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
PULMOLITEDiscontinued
TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT N/A · INJECTABLE · INJECTION
Approval history
2002-07-30Manufacturing (CMC) · Supplement 19 · standardAP
2001-05-24Manufacturing (CMC) · Supplement 18 · standardAP
2000-06-15Manufacturing (CMC) · Supplement 16 · standardAP
2000-02-07Manufacturing (CMC) · Supplement 15 · standardAP
1999-07-13Manufacturing (CMC) · Supplement 14 · standardAP
1998-03-24Manufacturing (CMC) · Supplement 13 · standardAP
1997-10-01Manufacturing (CMC) · Supplement 12 · standardAP
1995-01-25Manufacturing (CMC) · Supplement 11 · standardAP
1992-07-31Manufacturing (CMC) · Supplement 7 · standardAP
1989-05-19Labeling · Supplement 9AP
1989-05-02Manufacturing (CMC) · Supplement 10 · standardAP
1985-10-22Labeling · Supplement 5AP
1985-05-03Manufacturing (CMC) · Supplement 8 · standardAP
1983-05-31Manufacturing (CMC) · Supplement 6 · standardAP
1980-07-24Manufacturing (CMC) · Supplement 4 · standardAP
1976-11-16Type 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.