Drugs@FDA: FDA Approved Drug Products

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

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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