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Generated: April 30, 2017

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Details for New Drug Application (NDA): 017806

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NDA 017806 describes THALLOUS CHLORIDE TL 201, which is a drug marketed by Lantheus Medcl, Ge Healthcare, Bracco, Mallinkrodt Nuclear, and Trace Life, and is included in six NDAs. It is available from three 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. Three suppliers are listed for this compound. Additional details are available on the thallous chloride tl-201 profile page.

Summary for NDA: 017806

Formulation / Manufacturing:see details

Pharmacology for NDA: 017806

Mechanism of ActionRadiopharmaceutical 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
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
INJECTABLE;INJECTION 017806 NDA Lantheus Medical Imaging, Inc. 11994-427 11994-427-15 7.7 mL in 1 VIAL (11994-427-15)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1mCi/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength2mCi/ML
Approval Date:Oct 9, 1998TE:APRLD:Yes

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