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| FAMVIR | FAMCICLOVIR | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| FAMVIR | FAMCICLOVIR | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| FAMVIR | FAMCICLOVIR | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| 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 |