Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017771
Company: LANTHEUS MEDCL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TECHNELITE TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR 0.0083-2.7 CI/GENERATOR SOLUTION;INTRAVENOUS Discontinued None No No
TECHNELITE TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR 1-20 CI/GENERATOR SOLUTION;INTRAVENOUS Prescription None 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
11/16/1976 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
11/15/2016 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

08/27/2015 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

02/12/2016 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

02/09/2015 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

02/12/2014 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017771s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017771Orig1s035ltr.pdf
11/16/2012 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

03/25/2009 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

12/07/2007 SUPPL-24 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/02/2004 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

12/05/2001 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

12/06/2000 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

02/29/2000 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

08/11/2000 SUPPL-19 Labeling

Label is not available on this site.

02/04/1998 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

12/15/1997 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

11/05/1997 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

04/05/1996 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

01/24/1996 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

01/11/1996 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

05/23/1995 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/12/1993 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

01/12/1993 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

04/29/1985 SUPPL-9 Labeling

Label is not available on this site.

05/13/1983 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

04/18/1983 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

11/21/1978 SUPPL-5 Labeling

Label is not available on this site.

06/07/1978 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

10/11/1978 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
02/12/2014 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017771s035lbl.pdf

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