Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018150
Company: CURIUM
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/23/1979 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/13/2016 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018150s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018150Orig1s027ltr.pdf
01/12/2012 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018150s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018150s026ltr.pdf
06/22/2011 SUPPL-25 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018150s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018150s025ltr.pdf
04/16/2004 SUPPL-20 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18150scs020ltr.pdf
07/23/2004 SUPPL-19 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18150s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18150s019ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/018150_S019_Thallous Chloride T1-201_APPROVAL_PACKAGE.pdf
06/03/2002 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

09/27/2002 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

11/22/1999 SUPPL-13 Labeling

Label is not available on this site.

02/18/1997 SUPPL-12 Labeling

Label is not available on this site.

03/30/1994 SUPPL-11 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

12/16/1993 SUPPL-10 Efficacy-New Dosing Regimen

Label is not available on this site.

07/13/1988 SUPPL-9 Labeling

Label is not available on this site.

09/12/1984 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

11/27/1981 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/07/1982 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

05/13/1980 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/13/2016 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018150s027lbl.pdf
01/12/2012 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018150s026lbl.pdf
06/22/2011 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018150s025lbl.pdf
07/23/2004 SUPPL-19 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18150s019lbl.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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