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Last Updated: December 14, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 009190

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NDA 009190 describes LIPIODOL, which is a drug marketed by Guerbet and is included in one NDA. It is available from one supplier. Additional details are available on the LIPIODOL profile page.

The generic ingredient in LIPIODOL is ethiodized oil. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ethiodized oil profile page.
Summary for 009190
Tradename:LIPIODOL
Applicant:Guerbet
Ingredient:ethiodized oil
Patents:0
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 009190
Generic Entry Date for 009190*:
Constraining patent/regulatory exclusivity:
SELECTIVE HEPATIC INTRA-ARTERIAL USE FOR IMAGING TUMORS IN ADULTS WITH KNOWN HEPATOCELLULAR CARCINOMA (HCC)
Dosage:
OIL;INTRALYMPHATIC, INTRAUTERINE

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Medical Subject Heading (MeSH) Categories for 009190
Suppliers and Packaging for NDA: 009190
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LIPIODOL ethiodized oil OIL;INTRALYMPHATIC, INTRAUTERINE 009190 NDA Guerbet LLC 67684-1901 67684-1901-1 1 AMPULE in 1 CARTON (67684-1901-1) > 10 mL in 1 AMPULE
LIPIODOL ethiodized oil OIL;INTRALYMPHATIC, INTRAUTERINE 009190 NDA Guerbet LLC 67684-1901 67684-1901-2 1 VIAL in 1 CARTON (67684-1901-2) > 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OIL;INTRALYMPHATIC, INTRAUTERINEStrengthEQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 4, 2021
Regulatory Exclusivity Use:SELECTIVE HEPATIC INTRA-ARTERIAL USE FOR IMAGING TUMORS IN ADULTS WITH KNOWN HEPATOCELLULAR CARCINOMA (HCC)

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Serving leading biopharmaceutical companies globally:

McKesson
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