Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018110
Company: GE HEALTHCARE

Products on NDA 018110

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018110

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/01/1982	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
06/08/2016	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
05/12/2005	SUPPL-12	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018110s012ltr.pdf
11/14/2002	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
04/22/2002	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
01/10/2001	SUPPL-9	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
11/08/1995	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
03/03/1995	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
02/27/1996	SUPPL-6	Labeling		Label is not available on this site.
07/13/1990	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
06/06/1990	SUPPL-4	Manufacturing (CMC)-Formulation		Label is not available on this site.
01/28/1985	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
10/26/1982	SUPPL-2	Labeling		Label is not available on this site.