An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 201152
Company: BOEHRINGER INGELHEIM

Medication Guide

Medication Guide

Summary Review

Products on NDA 201152

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,TBD	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 201152

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
06/10/2022	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201152s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/201152Orig1s014ltr.pdf
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

Labels for NDA 201152

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/10/2022	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201152s014lbl.pdf
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

Therapeutic Equivalents for NDA 201152

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	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
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
VIRAMUNE XR	NEVIRAPINE	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	201152	BOEHRINGER INGELHEIM

Top