Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020363
Company: NOVARTIS
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| FAMVIR | FAMCICLOVIR | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| FAMVIR | FAMCICLOVIR | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| FAMVIR | FAMCICLOVIR | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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-Patient Package Insert, Labeling-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-Package Insert, Labeling-Patient 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 | Efficacy-Labeling Change With Clinical Data, Labeling |
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-Package Insert, Labeling-Container/Carton Labels |
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-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020363s050lbl.pdf | |
| 12/18/2018 | SUPPL-50 | Labeling-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-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020363s042lbl.pdf | |
| 04/24/2013 | SUPPL-42 | Labeling-Patient 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 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020363s037lbl.pdf | |
| 01/31/2011 | SUPPL-37 | Labeling | 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 |