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Last Updated: July 9, 2020

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Details for New Drug Application (NDA): 204508

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NDA 204508 describes CLINOLIPID 20%, which is a drug marketed by Baxter Hlthcare Corp and is included in one NDA. It is available from one supplier. Additional details are available on the CLINOLIPID 20% profile page.

The generic ingredient in CLINOLIPID 20% is olive oil; soybean oil. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the olive oil; soybean oil profile page.
Summary for 204508
Tradename:CLINOLIPID 20%
Applicant:Baxter Hlthcare Corp
Ingredient:olive oil; soybean oil
Pharmacology for NDA: 204508
Suppliers and Packaging for NDA: 204508
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLINOLIPID 20% olive oil; soybean oil EMULSION;INTRAVENOUS 204508 NDA Baxter Healthcare Corporation 0338-9540 0338-9540-05 15 BAG in 1 CARTON (0338-9540-05) > 100 mL in 1 BAG (0338-9540-01)
CLINOLIPID 20% olive oil; soybean oil EMULSION;INTRAVENOUS 204508 NDA Baxter Healthcare Corporation 0338-9540 0338-9540-06 10 BAG in 1 CARTON (0338-9540-06) > 250 mL in 1 BAG (0338-9540-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:EMULSION;INTRAVENOUSStrength16%(160GM/1000ML);4% (40GM/1000ML)
Approval Date:Oct 3, 2013TE:RLD:Yes

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