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Drugs@FDA: FDA-Approved Drugs

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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	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	207698	AUROBINDO PHARMA
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	208616	AUROBINDO PHARMA
VIRAMUNE XR	NEVIRAPINE	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	201152	BOEHRINGER INGELHEIM

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