FDA — authorised 14 May 2015
- Application: NDA204914
- Marketing authorisation holder: MYLAN LABS
- Local brand name: LAMIVUDINE; ZIDOVUDINE
- Indication: TABLET — ORAL SUSPENSION
- Status: approved
🇺🇸 Lamivudine/Zidovudine in United States
FDA authorised Lamivudine/Zidovudine on 14 May 2015
Marketing authorisations
FDA
- Application: NDA200748
- Marketing authorisation holder: MATRIX LABS LTD
- Local brand name: LAMIVUDINE; ZIDOVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA078929
- Marketing authorisation holder: EMCURE PHARMA
- Local brand name: LAMIVUDINE; ZIDOVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA202814
- Marketing authorisation holder: CIPLA LIMITED
- Local brand name: LAMIVUDINE; ZIDOVUDINE
- Indication: TABLET, FOR SUSPENSION — ORAL
- Status: approved
FDA
- Application: NDA201151
- Marketing authorisation holder: CIPLA LIMITED
- Local brand name: LAMIVUDINE; ZIDOVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA021943
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: LAMIVUDINE; ZIDOVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA022296
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: LAMIVUDINE; ZIDOVUDINE
- Indication: TABLET — ORAL
- Status: approved
Other Infectious Disease / Virology approved in United States
Frequently asked questions
Is Lamivudine/Zidovudine approved in United States?
Yes. FDA authorised it on 14 May 2015; FDA has authorised it; FDA has authorised it.
Who is the marketing authorisation holder for Lamivudine/Zidovudine in United States?
MYLAN LABS holds the US marketing authorisation.