Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020933
Company: BOEHRINGER INGELHEIM
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 |
|---|---|---|---|---|---|
| 06/10/2022 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020636s052,020933s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020636Orig1s052, 020933Orig1s043ltr.pdf | |
| 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 | REMS-Modified, Labeling |
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 |
|---|---|---|---|---|---|
| 06/10/2022 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020636s052,020933s043lbl.pdf | |
| 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 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020933s022,020636s032lbl.pdf | |
| 01/13/2010 | SUPPL-22 | Labeling | 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 |