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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 NDA: 009190

Tradename:
LIPIODOL
Applicant:
Guerbet
Ingredient:
ethiodized oil
Patents:0
Formulation / Manufacturing:see details

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

Summary 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:ORPHAN DRUG EXCLUSIVITY


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