Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 201152
Company: BOEHRINGER INGELHEIM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VIRAMUNE XR NEVIRAPINE 400MG TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes Yes
VIRAMUNE XR NEVIRAPINE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription AB 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
03/25/2011 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201152s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201152s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201152Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201152Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/24/2018 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201152s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/201152Orig1s013ltr.pdf
03/27/2017 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201152s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201152Orig1s010ltr.pdf
01/27/2014 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201152s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201152Orig1s007ltr.pdf
09/28/2012 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201152s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201152Orig1s005ltr.pdf
11/08/2012 SUPPL-4 Efficacy-Pediatric Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201152s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201152Orig1s004ltr.pdf
11/09/2011 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201152s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201152s002ltr.pdf
05/06/2011 SUPPL-1 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020933s029,020636s038,201152s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/24/2018 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201152s013lbl.pdf
03/27/2017 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201152s010lbl.pdf
01/27/2014 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201152s007lbl.pdf
11/08/2012 SUPPL-4 Efficacy-Pediatric Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201152s004lbl.pdf
09/28/2012 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201152s005lbl.pdf
11/09/2011 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201152s002lbl.pdf
03/25/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201152s000lbl.pdf

VIRAMUNE XR

TABLET, EXTENDED RELEASE;ORAL; 400MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NEVIRAPINE NEVIRAPINE 400MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204621 ALVOGEN
NEVIRAPINE NEVIRAPINE 400MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207698 AUROBINDO PHARMA LTD
NEVIRAPINE NEVIRAPINE 400MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206448 CIPLA
NEVIRAPINE NEVIRAPINE 400MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206879 MACLEODS PHARMS LTD
NEVIRAPINE NEVIRAPINE 400MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205651 MYLAN
NEVIRAPINE NEVIRAPINE 400MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203411 SANDOZ INC
VIRAMUNE XR NEVIRAPINE 400MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 201152 BOEHRINGER INGELHEIM

TABLET, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NEVIRAPINE NEVIRAPINE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204621 ALVOGEN
NEVIRAPINE NEVIRAPINE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 208616 AUROBINDO PHARMA LTD
NEVIRAPINE NEVIRAPINE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206271 MYLAN
VIRAMUNE XR NEVIRAPINE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 201152 BOEHRINGER INGELHEIM

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English