Details for New Drug Application (NDA): 022454

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NDA 022454 describes DATSCAN, which is a drug marketed by Ge Hlthcare Inc and is included in one NDA. It is available from one supplier. Additional details are available on the DATSCAN profile page.

The generic ingredient in DATSCAN is ioflupane i-123. Two suppliers are listed for this compound. Additional details are available on the ioflupane i-123 profile page.

Summary for 022454

Tradename:	DATSCAN
Applicant:	Ge Hlthcare Inc
Ingredient:	ioflupane i-123
Patents:	0

Pharmacology for NDA: 022454

Mechanism of Action	Radiopharmaceutical Activity

Suppliers and Packaging for NDA: 022454

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DATSCAN	ioflupane i-123	SOLUTION;INTRAVENOUS	022454	NDA	Medi-Physics Inc. dba GE Healthcare.	17156-210	17156-210-01	1 VIAL, GLASS in 1 CONTAINER (17156-210-01) / 2.5 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	5mCi/2.5ML (2mCi/ML)
Approval Date:	Jan 14, 2011	TE:	AP	RLD:	Yes

Expired US Patents for NDA 022454

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Hlthcare Inc	DATSCAN	ioflupane i-123	SOLUTION;INTRAVENOUS	022454-001	Jan 14, 2011	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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