Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020363
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FAMVIR FAMCICLOVIR 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
FAMVIR FAMCICLOVIR 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
FAMVIR FAMCICLOVIR 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/29/1994 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
12/18/2018 SUPPL-50 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020363s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020363Orig1s050ltr.pdf
12/09/2016 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

11/01/2016 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

09/16/2016 SUPPL-47 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020363s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020363Orig1s047ltr.pdf
09/10/2015 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

10/19/2015 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

05/14/2015 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

04/24/2013 SUPPL-42 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020363s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020363Orig1s042ltr.pdf
06/25/2014 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

02/09/2012 SUPPL-40 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020363s038s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020363s038,s040ltr.pdf
02/09/2012 SUPPL-38 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020363s038s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020363s038,s040ltr.pdf
01/31/2011 SUPPL-37 Labeling, Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020363s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020363s037ltr.pdf
12/24/2009 SUPPL-36 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020363s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020363s036ltr.pdf
12/22/2008 SUPPL-34 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020363s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020363s034ltr.pdf
06/06/2007 SUPPL-32 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

07/28/2006 SUPPL-28 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020363s027s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020363s027, 020363s028LTR.pdf
07/28/2006 SUPPL-27 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020363s027s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020363s027, 020363s028LTR.pdf
02/22/2006 SUPPL-26 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020363s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020363s026ltr.pdf
08/06/2002 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

03/29/2001 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20363S19LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20363S19LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-363S-019_review.pdf
02/02/1999 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

06/12/1998 SUPPL-16 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20363S14ltr.pdf
03/26/1998 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

06/12/1998 SUPPL-14 Efficacy-New Indication Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20363S14ltr.pdf
07/15/1997 SUPPL-13 Labeling

Label is not available on this site.

09/17/1997 SUPPL-12 Efficacy-New Indication

Label is not available on this site.

01/31/1997 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

06/12/1998 SUPPL-10 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20363S14ltr.pdf
01/13/1997 SUPPL-9 Labeling

Label is not available on this site.

04/26/1996 SUPPL-8 Labeling

Label is not available on this site.

07/29/1996 SUPPL-7 Labeling

Label is not available on this site.

09/08/1995 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/29/1996 SUPPL-5 Labeling

Label is not available on this site.

12/11/1995 SUPPL-4 Efficacy-New Indication

Label is not available on this site.

12/27/1994 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
12/18/2018 SUPPL-50 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020363s050lbl.pdf
12/18/2018 SUPPL-50 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020363s050lbl.pdf
09/16/2016 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020363s047lbl.pdf
04/24/2013 SUPPL-42 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020363s042lbl.pdf
04/24/2013 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020363s042lbl.pdf
02/09/2012 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020363s038s040lbl.pdf
02/09/2012 SUPPL-38 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020363s038s040lbl.pdf
01/31/2011 SUPPL-37 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020363s037lbl.pdf
01/31/2011 SUPPL-37 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020363s037lbl.pdf
12/24/2009 SUPPL-36 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020363s036lbl.pdf
12/22/2008 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020363s034lbl.pdf
07/28/2006 SUPPL-28 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020363s027s028lbl.pdf
07/28/2006 SUPPL-27 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020363s027s028lbl.pdf
02/22/2006 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020363s026lbl.pdf
03/29/2001 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20363S19LBL.PDF

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