FDA — authorised 6 April 2004
- Application: ANDA076192
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: RIBAVIRIN
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Rebetol in United States
FDA authorised Rebetol on 6 April 2004
Marketing authorisations
FDA — authorised 4 October 2004
- Application: ANDA076277
- Marketing authorisation holder: TEVA
- Local brand name: RIBAVIRIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 5 December 2005
- Application: ANDA077053
- Marketing authorisation holder: HERITAGE PHARMA AVET
- Local brand name: RIBAVIRIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 December 2005
- Application: ANDA077094
- Marketing authorisation holder: ZYDUS PHARMS USA
- Local brand name: RIBAVIRIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 December 2005
- Application: ANDA077456
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: RIBAVIRIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 October 2006
- Application: ANDA077743
- Marketing authorisation holder: SANDOZ
- Local brand name: RIBAVIRIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 September 2009
- Application: ANDA079117
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: RIBAVIRIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 12 August 2014
- Application: ANDA202546
- Marketing authorisation holder: BEXIMCO PHARMS USA
- Local brand name: RIBAVIRIN
- Indication: TABLET — ORAL
- Status: approved
Other Other approved in United States
Frequently asked questions
Is Rebetol approved in United States?
Yes. FDA authorised it on 6 April 2004; FDA authorised it on 4 October 2004; FDA authorised it on 5 December 2005.
Who is the marketing authorisation holder for Rebetol in United States?
CHARTWELL RX holds the US marketing authorisation.