FDA.reportPublic FDA data

Application 009190

Type
NDA
Sponsor
GUERBET

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LIPIODOLETHIODIZED OILOIL;INTRALYMPHATIC, INTRAUTERINEEQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67684-1901LIPIODOLethiodized oilGuerbet LLCNDACurrent
67684-1901LIPIODOLethiodized oilGuerbet LLCNDACurrent
67684-1901LIPIODOLethiodized oilGuerbet LLCNDACurrent
67684-1901LIPIODOLethiodized oilGuerbet LLCNDACurrent
67684-1901LIPIODOLethiodized oilGuerbet LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73966SUPPL 2023-04-10
73953SUPPL 2023-04-06
63509SUPPL2020-06-12
63508SUPPL2020-06-12
63494SUPPL2020-06-12
63493SUPPL2020-06-12
10720SUPPL2014-04-08
177SUPPL2014-04-07
32992SUPPL2014-03-25
176SUPPL2014-03-24