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Generated: January 19, 2019

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Details for New Drug Application (NDA): 018150

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NDA 018150 describes THALLOUS CHLORIDE TL 201, which is a drug marketed by Bracco, Ge Healthcare, Lantheus Medcl, 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 018150
Tradename:THALLOUS CHLORIDE TL 201
Applicant:Mallinkrodt Nuclear
Ingredient:thallous chloride tl-201
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 018150
Mechanism of ActionRadiopharmaceutical Activity
Suppliers and Packaging for NDA: 018150
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
THALLOUS CHLORIDE TL 201 thallous chloride tl-201 INJECTABLE;INJECTION 018150 NDA Curium US LLC 69945-120 69945-120-28 1 VIAL in 1 CAN (69945-120-28) > 2.8 mL in 1 VIAL
THALLOUS CHLORIDE TL 201 thallous chloride tl-201 INJECTABLE;INJECTION 018150 NDA Curium US LLC 69945-120 69945-120-56 1 VIAL in 1 CAN (69945-120-56) > 5.6 mL in 1 VIAL

Profile for product number 001

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

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