Drugs@FDA: FDA Approved Drug Products

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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 Prescription AP Yes Yes
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

THALLOUS CHLORIDE TL 201

INJECTABLE;INJECTION; 1mCi/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
THALLOUS CHLORIDE TL 201 THALLOUS CHLORIDE TL-201 1mCi/ML INJECTABLE;INJECTION Prescription Yes AP 018150 CURIUM
THALLOUS CHLORIDE TL 201 THALLOUS CHLORIDE TL-201 1mCi/ML INJECTABLE;INJECTION Prescription Yes AP 018110 GE HEALTHCARE
THALLOUS CHLORIDE TL 201 THALLOUS CHLORIDE TL-201 1mCi/ML INJECTABLE;INJECTION Prescription Yes AP 017806 LANTHEUS MEDCL

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