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Generated: December 13, 2017

DrugPatentWatch Database Preview

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 two 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:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 204508

Ingredient-typeLipids

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 INJECTABLE;INJECTION 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)
CLINOLIPID 20% olive oil; soybean oil INJECTABLE;INJECTION 204508 NDA Baxter Healthcare Corporation 0338-9540 0338-9540-08 6 BAG in 1 CARTON (0338-9540-08) > 1000 mL in 1 BAG (0338-9540-04)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength16%(160GM/1000ML);4% (40GM/1000ML)
Approval Date:Oct 3, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 3, 2016
Regulatory Exclusivity Use:NEW PRODUCT

Expired Orange Book Patents for NDA: 204508

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Baxter Hlthcare CorpCLINOLIPID 20%olive oil; soybean oilINJECTABLE;INJECTION204508-001Oct 3, 2013► Subscribe► Subscribe
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