FDA — authorised 19 September 2005
- Application: ANDA076844
- Marketing authorisation holder: HIKMA
- Local brand name: ZIDOVUDINE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Lamivudine, Zidovudine and nevirapine in United States
FDA authorised Lamivudine, Zidovudine and nevirapine on 19 September 2005
Marketing authorisations
FDA — authorised 23 May 2007
- Application: ANDA078349
- Marketing authorisation holder: CIPLA LTD
- Local brand name: ZIDOVUDINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 14 February 2008
- Application: ANDA078922
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: ZIDOVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 April 2008
- Application: ANDA090092
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: ZIDOVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 June 2008
- Application: ANDA077981
- Marketing authorisation holder: CIPLA LTD
- Local brand name: ZIDOVUDINE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 6 May 2010
- Application: ANDA091457
- Marketing authorisation holder: AM REGENT
- Local brand name: ZIDOVUDINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 October 2010
- Application: ANDA090561
- Marketing authorisation holder: CIPLA
- Local brand name: ZIDOVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 February 2011
- Application: NDA200732
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: ZIDOVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA077327
- Marketing authorisation holder: RANBAXY LABS LTD
- Local brand name: ZIDOVUDINE
- Indication: TABLET — ORAL
- Status: approved
Frequently asked questions
Is Lamivudine, Zidovudine and nevirapine approved in United States?
Yes. FDA authorised it on 19 September 2005; FDA authorised it on 23 May 2007; FDA authorised it on 14 February 2008.
Who is the marketing authorisation holder for Lamivudine, Zidovudine and nevirapine in United States?
HIKMA holds the US marketing authorisation.