← FDA DRUG APPROVALS

FDA NDA · NDA019710

OPTIRAY 320

ioversol

Sponsor: LIEBEL-FLARSHEIM

APPLICATION
NDA019710
TYPE
NDA
ORIGINAL APPROVAL
1988-12-30
LATEST ACTION
2023-04-25
ROUTE
INTRA-ARTERIAL, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued

Products

OPTIRAY 350 · ReferencePrescription
IOVERSOL 74% · INJECTABLE · INJECTION
OPTIRAY 160Discontinued
IOVERSOL 34% · INJECTABLE · INJECTION
OPTIRAY 320 · ReferencePrescription
IOVERSOL 68% · INJECTABLE · INJECTION
OPTIRAY 300 · ReferencePrescription
IOVERSOL 64% · INJECTABLE · INJECTION
OPTIRAY 240 · ReferenceDiscontinued
IOVERSOL 51% · INJECTABLE · INJECTION

Approval history

2023-04-25Labeling · Supplement 67 · standard — Letter ↗AP
2022-05-04Labeling · Supplement 64 · standard — Letter ↗AP
2022-02-18Labeling · Supplement 65 · standard — Letter ↗AP
2020-01-23Labeling · Supplement 58 · standard — Letter ↗AP
2017-04-26Labeling · Supplement 54 · standard — Label ↗AP
2017-04-05Labeling · Supplement 55 · standard — Label ↗AP
2016-08-12Labeling · Supplement 39 · standard — Label ↗AP
2016-05-13Manufacturing (CMC) · Supplement 53 · standardAP
2015-07-06Labeling · Supplement 52 · standard — Label ↗AP
2013-12-19Manufacturing (CMC) · Supplement 50 · standardAP
2013-12-06Manufacturing (CMC) · Supplement 51 · standardAP
2009-08-08Labeling · Supplement 35 · standardAP
2008-04-25Labeling · Supplement 34 · standard — Letter ↗AP
2008-04-25Labeling · Supplement 32 · standard — Letter ↗AP
2007-08-28Manufacturing (CMC) · Supplement 33AP
2006-03-15Manufacturing (CMC) · Supplement 30AP
2001-09-12Manufacturing (CMC) · Supplement 26 · standardAP
2001-08-02Manufacturing (CMC) · Supplement 27 · standardAP
2001-01-23Manufacturing (CMC) · Supplement 25 · standardAP
1999-10-27Manufacturing (CMC) · Supplement 24 · standardAP
1999-04-16Manufacturing (CMC) · Supplement 23 · standardAP
1999-03-25Manufacturing (CMC) · Supplement 22 · standardAP
1997-05-23Manufacturing (CMC) · Supplement 21 · standard — Review ↗AP
1996-07-12Manufacturing (CMC) · Supplement 13 · standardAP
1995-06-21Efficacy · Supplement 18 · standardAP
1995-01-13Labeling · Supplement 19 · standardAP
1993-09-22Manufacturing (CMC) · Supplement 10 · standardAP
1993-07-27Efficacy · Supplement 17AP
1993-03-09Efficacy · Supplement 16AP
1992-12-11Efficacy · Supplement 12AP
1992-12-04Manufacturing (CMC) · Supplement 8 · standardAP
1992-10-26Manufacturing (CMC) · Supplement 11 · standardAP
1992-08-28Manufacturing (CMC) · Supplement 9 · standardAP
1992-07-09Efficacy · Supplement 7AP
1992-01-22Manufacturing (CMC) · Supplement 5 · standardAP
1992-01-22Efficacy · Supplement 4AP
1990-03-30Manufacturing (CMC) · Supplement 3 · standardAP
1989-10-10Manufacturing (CMC) · Supplement 2 · standardAP
1989-04-17Labeling · Supplement 1AP
1988-12-30Type 1 - New Molecular Entity · Original · standardAP
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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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