U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 017806
Company: LANTHEUS MEDCL

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THALLOUS CHLORIDE TL 201 THALLOUS CHLORIDE TL-201 1mCi/ML INJECTABLE;INJECTION Discontinued None Yes No
THALLOUS CHLORIDE TL 201 THALLOUS CHLORIDE TL-201 2mCi/ML INJECTABLE;INTRAVENOUS Discontinued None Yes No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/16/1977 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/25/2011 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017806s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017806s025ltr.pdf
10/09/1998 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.
03/07/1997 SUPPL-23 Labeling

Label is not available on this site.
02/24/1995 SUPPL-22 Efficacy-New Indication

Label is not available on this site.
12/09/1986 SUPPL-21 Efficacy-New Indication

Label is not available on this site.
12/09/1986 SUPPL-20 Efficacy-New Indication

Label is not available on this site.
03/15/1984 SUPPL-19 Labeling

Label is not available on this site.
03/08/1983 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.
03/10/1983 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.
02/22/1983 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.
10/18/1982 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.
09/14/1982 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.
12/31/1981 SUPPL-12 Labeling

Label is not available on this site.
04/25/1981 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.
04/30/1981 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.
02/08/1982 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.
12/26/1979 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.
04/19/1979 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.
04/12/1979 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.
08/11/1978 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.
08/11/1978 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.
07/14/1978 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
08/25/2011 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017806s025lbl.pdf
Back to Top