Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020933
Company: BOEHRINGER INGELHEIM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VIRAMUNE NEVIRAPINE 50MG/5ML SUSPENSION;ORAL Prescription AA Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/11/1998 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-933_Viramune_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-933_Viramune_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-933_20-636S009_Viramune.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/24/2018 SUPPL-40 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020636s050,020933s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020636Orig1s050,020933Orig1s040ltr.pdf
03/27/2017 SUPPL-38 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020636s048,020933s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020636Orig1s048,020933Orig1s038ltr.pdf
02/03/2015 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

01/27/2014 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020636s044,020933s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020636Orig1s044,020933Orig1s035ltr.pdf
02/08/2013 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

11/09/2012 SUPPL-33 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020636s042,020933s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020636Orig1s042,020933Orig1s033ltr.pdf
11/09/2011 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020636s039_020933s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020636s039,020933s030ltr.pdf
05/06/2011 SUPPL-29 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020933s029,020636s038,201152s001ltr.pdf
03/25/2011 SUPPL-28 Labeling-Package Insert, REMS-Modified, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020933s028,020636s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020933s028,020636s037ltr.pdf
01/07/2011 SUPPL-27 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020636s036,020933s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020636s036,020933s027ltr.pdf
07/20/2010 SUPPL-26 Labeling-Package Insert, REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020636s035,020933s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020636s035,020933s026ltr.pdf
01/13/2010 SUPPL-22 Labeling, REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020933s022,020636s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020933s022,020636s032ltr.pdf
08/16/2007 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020636s029,020933s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020636s029,020933s019ltr.pdf
06/24/2008 SUPPL-17 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020636s027,020933s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020636s027, 020933s017ltr.pdf
04/13/2007 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020636s026,020933s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020636s026,020933s015ltr.pdf
02/24/2005 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20636s025,20933s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20636s025,20933s014ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020933_S014_VIRAMUNE.pdf
05/24/2004 SUPPL-12 Labeling

Label is not available on this site.

12/22/2003 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20636slr021,20933slr011_viramune_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20636slr021,20933slr011ltr.pdf
07/29/2003 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20636slr020,20933slr010_viramune_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20636slr020,20933slr010ltr.pdf
12/20/2002 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

03/27/2002 SUPPL-7 Efficacy-Accelerated Approval Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20636s17ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020636s017_020933s007_Viramune.cfm
12/31/2002 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20636slr016,20933slr006_viramune_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20636slr016,20933slr006ltr.pdf
02/23/2001 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

05/17/2001 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/06/2000 SUPPL-3 Labeling

Label is not available on this site.

08/10/2000 SUPPL-2 Labeling

Label is not available on this site.

10/25/1999 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/24/2018 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020636s050,020933s040lbl.pdf
03/27/2017 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020636s048,020933s038lbl.pdf
01/27/2014 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020636s044,020933s035lbl.pdf
11/09/2012 SUPPL-33 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020636s042,020933s033lbl.pdf
11/09/2011 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020636s039_020933s030lbl.pdf
03/25/2011 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020933s028,020636s037lbl.pdf
03/25/2011 SUPPL-28 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020933s028,020636s037lbl.pdf
03/25/2011 SUPPL-28 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020933s028,020636s037lbl.pdf
01/07/2011 SUPPL-27 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020636s036,020933s027lbl.pdf
07/20/2010 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020636s035,020933s026lbl.pdf
07/20/2010 SUPPL-26 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020636s035,020933s026lbl.pdf
01/13/2010 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020933s022,020636s032lbl.pdf
01/13/2010 SUPPL-22 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020933s022,020636s032lbl.pdf
06/24/2008 SUPPL-17 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020636s027,020933s017lbl.pdf
08/16/2007 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020636s029,020933s019lbl.pdf
04/13/2007 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020636s026,020933s015lbl.pdf
02/24/2005 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20636s025,20933s014lbl.pdf
12/22/2003 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20636slr021,20933slr011_viramune_lbl.pdf
07/29/2003 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20636slr020,20933slr010_viramune_lbl.pdf
12/31/2002 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20636slr016,20933slr006_viramune_lbl.pdf
09/11/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-933_Viramune_Prntlbl.pdf

VIRAMUNE

SUSPENSION;ORAL; 50MG/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NEVIRAPINE NEVIRAPINE 50MG/5ML SUSPENSION;ORAL Prescription No AA 077702 AUROBINDO
NEVIRAPINE NEVIRAPINE 50MG/5ML SUSPENSION;ORAL Prescription No AA 207684 CIPLA
VIRAMUNE NEVIRAPINE 50MG/5ML SUSPENSION;ORAL Prescription Yes AA 020933 BOEHRINGER INGELHEIM

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