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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 and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. 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 NDA: 204508

Tradename:
CLINOLIPID 20%
Applicant:
Baxter Hlthcare
Ingredient:
olive oil; soybean oil
Patents:1
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 0338-9540-05 15 BAG in 1 CARTON (0338-9540-05) > 100 mL in 1 BAG (0338-9540-01)
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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength16%(160GM/1000ML);4% (40GM/1000ML)
Approval Date:Oct 3, 2013TE:RLD:Yes
Patent:5,840,757Patent Expiration:Nov 24, 2015Product Flag?YSubstance Flag?Delist Request?
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
CLINOLIPID 20%
olive oil; soybean oil
INJECTABLE;INJECTION204508-001Oct 3, 20135,840,757► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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