FDA — authorised 21 June 1996
- Application: NDA020636
- Marketing authorisation holder: BOEHRINGER INGELHEIM
- Local brand name: VIRAMUNE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Viramune in United States
FDA authorised Viramune on 21 June 1996
Marketing authorisations
FDA — authorised 21 June 1996
- Marketing authorisation holder: BOEHRINGER INGELHEIM
- Status: approved
FDA — authorised 11 September 1998
- Application: NDA020933
- Marketing authorisation holder: BOEHRINGER INGELHEIM
- Local brand name: VIRAMUNE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 25 March 2011
- Application: NDA201152
- Marketing authorisation holder: BOEHRINGER INGELHEIM
- Local brand name: VIRAMUNE XR
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 22 May 2012
- Application: ANDA077956
- Marketing authorisation holder: CIPLA
- Local brand name: NEVIRAPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 May 2012
- Application: ANDA203080
- Marketing authorisation holder: MICRO LABS LTD
- Local brand name: NEVIRAPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 May 2012
- Application: ANDA203176
- Marketing authorisation holder: TECH ORGANIZED
- Local brand name: NEVIRAPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 May 2012
- Application: ANDA077521
- Marketing authorisation holder: AUROBINDO
- Local brand name: NEVIRAPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 May 2012
- Application: ANDA202523
- Marketing authorisation holder: MYLAN PHARMS INC
- Local brand name: NEVIRAPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 May 2012
- Application: ANDA078584
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: NEVIRAPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 May 2012
- Application: ANDA077702
- Marketing authorisation holder: AUROBINDO
- Local brand name: NEVIRAPINE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 22 May 2012
- Application: ANDA203021
- Marketing authorisation holder: APOTEX INC
- Local brand name: NEVIRAPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 May 2012
- Application: ANDA078644
- Marketing authorisation holder: PRINSTON INC
- Local brand name: NEVIRAPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 May 2012
- Application: ANDA078864
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: NEVIRAPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 April 2014
- Application: ANDA203411
- Marketing authorisation holder: SANDOZ
- Local brand name: NEVIRAPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 3 April 2014
- Application: ANDA205258
- Marketing authorisation holder: APOTEX
- Local brand name: NEVIRAPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 27 October 2014
- Application: ANDA205651
- Marketing authorisation holder: MYLAN
- Local brand name: NEVIRAPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 10 July 2015
- Application: ANDA204621
- Marketing authorisation holder: ALVOGEN
- Local brand name: NEVIRAPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 15 October 2015
- Application: ANDA206448
- Marketing authorisation holder: CIPLA
- Local brand name: NEVIRAPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 9 November 2015
- Application: ANDA206271
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: NEVIRAPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 23 November 2016
- Application: ANDA208616
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: NEVIRAPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 28 February 2017
- Application: ANDA207698
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: NEVIRAPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 31 July 2017
- Application: ANDA207467
- Marketing authorisation holder: TECH ORGANIZED
- Local brand name: NEVIRAPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 3 August 2017
- Application: ANDA207684
- Marketing authorisation holder: CIPLA
- Local brand name: NEVIRAPINE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 6 October 2017
- Application: ANDA206879
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: NEVIRAPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 14 January 2019
- Application: ANDA090688
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: NEVIRAPINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA077429
- Marketing authorisation holder: RANBAXY
- Local brand name: NEVIRAPINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA205921
- Marketing authorisation holder: MYLAN LABS LTD
- Local brand name: NEVIRAPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA078887
- Marketing authorisation holder: EMCURE PHARMA
- Local brand name: NEVIRAPINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA207064
- Marketing authorisation holder: CIPLA LIMITED
- Local brand name: NEVIRAPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: NDA202212
- Marketing authorisation holder: CIPLA LIMITED
- Local brand name: NEVIRAPINE
- Indication: TABLET, FOR SUSPENSION — ORAL
- Status: approved
FDA
- Application: NDA022299
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: NEVIRAPINE TABLETS FOR ORAL SUSPENSION
- Indication: TABLET — ORAL
- Status: approved
Viramune in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Viramune approved in United States?
Yes. FDA authorised it on 21 June 1996; FDA authorised it on 21 June 1996; FDA authorised it on 11 September 1998.
Who is the marketing authorisation holder for Viramune in United States?
BOEHRINGER INGELHEIM holds the US marketing authorisation.