← FDA DRUG APPROVALS

FDA NDA · NDA020923

OPTIRAY 320

ioversol

Sponsor: LIEBEL-FLARSHEIM

APPLICATION
NDA020923
TYPE
NDA
ORIGINAL APPROVAL
1998-05-29
LATEST ACTION
2023-04-25
ROUTE
INTRA-ARTERIAL, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription

Products

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

Approval history

2023-04-25Labeling · Supplement 30 · standard — Letter ↗AP
2022-02-18Labeling · Supplement 28 · standard — Letter ↗AP
2020-11-18Labeling · Supplement 25 · standard — Label ↗AP
2020-11-18Labeling · Supplement 26 · standard — Label ↗AP
2017-12-12Labeling · Supplement 21 · standard — Label ↗AP
2017-04-26Labeling · Supplement 19 · standard — Label ↗AP
2017-04-05Labeling · Supplement 20 · standard — Label ↗AP
2016-08-12Labeling · Supplement 9 · standard — Label ↗AP
2015-07-06Labeling · Supplement 18 · standard — Label ↗AP
2013-12-19Manufacturing (CMC) · Supplement 16 · standardAP
2009-08-08Labeling · Supplement 5 · standardAP
2001-09-12Manufacturing (CMC) · Supplement 3 · standardAP
1999-07-14Manufacturing (CMC) · Supplement 2 · standardAP
1999-05-13Manufacturing (CMC) · Supplement 1 · standardAP
1998-05-29Type 3 - New Dosage Form · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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