APPLICATION
NDA018905
TYPE
NDA
ORIGINAL APPROVAL
1985-07-26
LATEST ACTION
2017-04-05
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
HEXABRIXDiscontinued
IOXAGLATE MEGLUMINE 39.3%, IOXAGLATE SODIUM 19.6% · INJECTABLE · INJECTION
Approval history
2001-02-23Manufacturing (CMC) · Supplement 22 · standardAP
1999-10-27Manufacturing (CMC) · Supplement 21 · standardAP
1995-04-26Manufacturing (CMC) · Supplement 20 · standardAP
1995-01-13Labeling · Supplement 19 · standardAP
1994-03-30Manufacturing (CMC) · Supplement 14 · standardAP
1994-03-17Manufacturing (CMC) · Supplement 16 · standardAP
1992-12-04Manufacturing (CMC) · Supplement 15 · standardAP
1992-08-28Manufacturing (CMC) · Supplement 17 · standardAP
1990-03-30Manufacturing (CMC) · Supplement 13 · standardAP
1989-10-10Manufacturing (CMC) · Supplement 7 · standardAP
1989-07-03Labeling · Supplement 12AP
1989-01-31Manufacturing (CMC) · Supplement 10 · standardAP
1988-06-03Manufacturing (CMC) · Supplement 1 · standardAP
1986-12-30Labeling · Supplement 6AP
1986-11-21Labeling · Supplement 4AP
1986-10-22Efficacy · Supplement 2AP
1985-07-26Type 1 - New Molecular Entity and Type 4 - New Combination · 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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