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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020636
Company: BOEHRINGER INGELHEIM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VIRAMUNE NEVIRAPINE 200MG TABLET;ORAL Prescription AB Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/10/2022 SUPPL-52 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020636s052,020933s043lbl.pdf
09/24/2018 SUPPL-50 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020636s050,020933s040lbl.pdf
03/27/2017 SUPPL-48 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020636s048,020933s038lbl.pdf
01/27/2014 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020636s044,020933s035lbl.pdf
11/09/2012 SUPPL-42 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020636s042,020933s033lbl.pdf
11/09/2011 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020636s039_020933s030lbl.pdf
03/25/2011 SUPPL-37 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020933s028,020636s037lbl.pdf
03/25/2011 SUPPL-37 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020933s028,020636s037lbl.pdf
03/25/2011 SUPPL-37 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020933s028,020636s037lbl.pdf
01/07/2011 SUPPL-36 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020636s036,020933s027lbl.pdf
07/20/2010 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020636s035,020933s026lbl.pdf
07/20/2010 SUPPL-35 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020636s035,020933s026lbl.pdf
01/13/2010 SUPPL-32 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020933s022,020636s032lbl.pdf
01/13/2010 SUPPL-32 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020933s022,020636s032lbl.pdf
06/24/2008 SUPPL-27 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020636s027,020933s017lbl.pdf
06/24/2008 SUPPL-27 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020636s027,020933s017lbl.pdf
08/16/2007 SUPPL-29 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020636s029,020933s019lbl.pdf
04/13/2007 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020636s026,020933s015lbl.pdf
02/24/2005 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20636s025,20933s014lbl.pdf
05/24/2004 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20636slr022_viramune_lbl.pdf
12/22/2003 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20636slr021,20933slr011_viramune_lbl.pdf
07/29/2003 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20636slr020,20933slr010_viramune_lbl.pdf
12/31/2002 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20636slr016,20933slr006_viramune_lbl.pdf
09/11/1998 SUPPL-9 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-933_Viramune_Prntlbl.pdf
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