APPLICATION
NDA020256
TYPE
NDA
ORIGINAL APPROVAL
1994-11-23
LATEST ACTION
2015-02-03
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
NEUROLITE · ReferencePrescription
TECHNETIUM TC-99M BICISATE KIT N/A · INJECTABLE · INJECTION
Approval history
2015-02-03Manufacturing (CMC) · Supplement 15 · standardAP
2000-05-18Manufacturing (CMC) · Supplement 8 · standardAP
2000-02-24Labeling · Supplement 7 · standardAP
1999-04-26Manufacturing (CMC) · Supplement 6 · standardAP
1998-12-30Manufacturing (CMC) · Supplement 5 · standardAP
1998-05-15Manufacturing (CMC) · Supplement 4 · standardAP
1997-09-12Manufacturing (CMC) · Supplement 3 · standardAP
1997-01-16Manufacturing (CMC) · Supplement 1 · standardAP
1996-11-12Manufacturing (CMC) · Supplement 2 · standardAP
1994-11-23Type 1 - New Molecular Entity · 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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