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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020372
Company: GE HEALTHCARE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MYOVIEW TECHNETIUM TC-99M TETROFOSMIN KIT N/A INJECTABLE;INJECTION Prescription None Yes Yes
MYOVIEW 30ML TECHNETIUM TC-99M TETROFOSMIN KIT N/A INJECTABLE;INJECTION 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
02/09/1996 ORIG-1 Approval Type 1 - New Molecular Entity 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
12/06/2022 SUPPL-33 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020372Orig1s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020372Orig1s033ltr.pdf
03/09/2022 SUPPL-31 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020372Orig1s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020372Orig1s031ltr.pdf
04/17/2017 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020372s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020372Orig1s028ltr.pdf
03/08/2013 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.
02/26/2009 SUPPL-22 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020372s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020372s022ltr.pdf
07/07/2005 SUPPL-19 Manufacturing (CMC)-Formulation Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020372s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020372s019ltr.pdf
11/13/2003 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20372slr015_myoview_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20372slr015ltr.pdf
02/28/2003 SUPPL-13 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020372s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20372se1-013ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-372s013_Myoview.cfm
11/25/2002 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.
05/22/2002 SUPPL-11 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20372scm011ltr.pdf
12/04/2001 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.
08/27/2001 SUPPL-9 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20372s9lbl.pdf
04/10/2001 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.
09/29/2000 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.
04/12/2000 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
04/13/2000 SUPPL-5 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
11/12/1999 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.
11/23/2001 SUPPL-3 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20372_Myoview_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20372_Myoview_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20372_Myoview.cfm
12/09/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
12/07/1998 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
12/06/2022 SUPPL-33 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020372Orig1s033lbl.pdf
12/06/2022 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020372Orig1s033lbl.pdf
03/09/2022 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020372Orig1s031lbl.pdf
03/09/2022 SUPPL-31 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020372Orig1s031lbl.pdf
04/17/2017 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020372s028lbl.pdf
02/26/2009 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020372s022lbl.pdf
02/26/2009 SUPPL-22 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020372s022lbl.pdf
07/07/2005 SUPPL-19 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020372s019lbl.pdf
11/13/2003 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20372slr015_myoview_lbl.pdf
02/28/2003 SUPPL-13 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020372s013lbl.pdf
11/23/2001 SUPPL-3 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20372_Myoview_prntlbl.pdf
08/27/2001 SUPPL-9 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20372s9lbl.pdf
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