FDA — authorised 15 January 2015
- Application: ANDA202573
- Marketing authorisation holder: CIPLA
- Local brand name: RITONAVIR
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Norvir in United States
FDA authorised Norvir on 15 January 2015
Marketing authorisations
FDA — authorised 27 March 2015
- Application: NDA022417
- Marketing authorisation holder: ABBVIE
- Indication: Labeling
- Status: approved
FDA — authorised 17 September 2018
- Application: ANDA204587
- Marketing authorisation holder: HETERO LABS LTD III
- Status: approved
FDA — authorised 17 September 2018
- Application: ANDA206614
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Status: approved
FDA — authorised 4 June 2021
- Application: ANDA091677
- Marketing authorisation holder: HETERO LABS LTD III
- Status: approved
FDA — authorised 10 May 2022
- Application: ANDA203759
- Marketing authorisation holder: CIPLA
- Local brand name: RITONAVIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 November 2024
- Application: NDA217188
- Marketing authorisation holder: PFIZER
- Indication: Labeling
- Status: approved
The FDA approved Norvir, manufactured by Pfizer, for labeling on November 19, 2024. This approval was granted under the standard expedited pathway. Norvir is a medication used for its intended labeling.
FDA
- Application: NDA205040
- Marketing authorisation holder: CIPLA LIMITED
- Local brand name: RITONAVIR
- Indication: TABLET — ORAL
- Status: approved
Norvir in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Norvir approved in United States?
Yes. FDA authorised it on 15 January 2015; FDA authorised it on 27 March 2015; FDA authorised it on 17 September 2018.
Who is the marketing authorisation holder for Norvir in United States?
CIPLA holds the US marketing authorisation.