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
Patents:	0

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 204508

Generic Entry Date for 204508^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: NEW PATIENT POPULATION Dosage: EMULSION;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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:	RX	Dosage:	EMULSION;INTRAVENOUS			Strength	16%(160GM/1000ML);4% (40GM/1000ML)
Approval Date:	Oct 3, 2013	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Apr 24, 2027
Regulatory Exclusivity Use:	NEW PATIENT POPULATION

Expired US Patents for NDA 204508

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Baxter Hlthcare Corp	CLINOLIPID 20%	olive oil; soybean oil	EMULSION;INTRAVENOUS	204508-001	Oct 3, 2013	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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