Details for New Drug Application (NDA): 017806

NDA 017806 describes THALLOUS CHLORIDE TL 201, which is a drug marketed by Bracco, Curium, Ge Healthcare, Lantheus Medcl, and Trace Life, and is included in six NDAs. It is available from two suppliers. Additional details are available on the THALLOUS CHLORIDE TL 201 profile page.

The generic ingredient in THALLOUS CHLORIDE TL 201 is thallous chloride tl-201. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the thallous chloride tl-201 profile page.

Summary for 017806

Tradename:	THALLOUS CHLORIDE TL 201
Applicant:	Lantheus Medcl
Ingredient:	thallous chloride tl-201
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 017806

Mechanism of Action

Radiopharmaceutical Activity

Suppliers and Packaging for NDA: 017806

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
THALLOUS CHLORIDE TL 201	thallous chloride tl-201	INJECTABLE;INJECTION	017806	NDA	Lantheus Medical Imaging, Inc.	11994-427	11994-427-11	5.5 mL in 1 VIAL (11994-427-11)
THALLOUS CHLORIDE TL 201	thallous chloride tl-201	INJECTABLE;INJECTION	017806	NDA	Lantheus Medical Imaging, Inc.	11994-427	11994-427-15	7.7 mL in 1 VIAL (11994-427-15)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1mCi/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AP	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	2mCi/ML
Approval Date:	Oct 9, 1998	TE:		RLD:	Yes

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