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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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/07/2022 SUPPL-33 Tentative Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020372Orig1s033lbl.pdf
03/09/2022 SUPPL-31 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020372Orig1s031lbl.pdf
03/09/2022 SUPPL-31 Labeling-Package Insert 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-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020372s022lbl.pdf
02/26/2009 SUPPL-22 Labeling-Package Insert 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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