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FDA NDA · NDA009190

LIPIODOL

ethiodized oil

Sponsor: GUERBET

APPLICATION
NDA009190
TYPE
NDA
ORIGINAL APPROVAL
1954-03-31
LATEST ACTION
2023-04-05
ROUTE
INTRA-ARTERIAL, INTRALYMPHATIC, INTRAUTERINE, INTRALYMPHATIC, INTRAUTERINE
DOSAGE FORM
OIL
MARKETING STATUS
Prescription

Products

LIPIODOL · ReferencePrescription
ETHIODIZED OIL EQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML) · OIL · INTRALYMPHATIC, INTRAUTERINE

Approval history

2023-04-05Labeling · Supplement 32 · standard — Letter ↗AP
2020-06-10Labeling · Supplement 29 · standard — Letter ↗AP
2020-06-10Labeling · Supplement 31 · standard — Letter ↗AP
2018-09-28Manufacturing (CMC) · Supplement 27AP
2014-04-04Efficacy · Supplement 24 · standard — Label ↗AP
2014-03-21Labeling · Supplement 21 · standard — Letter ↗AP
2014-01-23Manufacturing (CMC) · Supplement 22 · priorityAP
1985-09-10Labeling · Supplement 16AP
1979-11-14Manufacturing (CMC) · Supplement 11 · priorityAP
1979-11-14Manufacturing (CMC) · Supplement 10 · priorityAP
1978-02-07Manufacturing (CMC) · Supplement 9 · priorityAP
1954-03-31Type 1 - New Molecular Entity · Original · priorityAP
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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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