Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018150
Company: CURIUM

Products on NDA 018150

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018150

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.

Labels for NDA 018150

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

Therapeutic Equivalents for NDA 018150

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