FDA — authorised 19 March 2003
- Application: ANDA040442
- Marketing authorisation holder: GENUS
- Status: approved
🇺🇸 Karbinal Er in United States
FDA authorised Karbinal Er on 19 March 2003
Marketing authorisations
FDA — authorised 7 June 2006
- Application: ANDA040458
- Marketing authorisation holder: GENUS
- Indication: Labeling
- Status: approved
FDA — authorised 27 May 2011
- Application: ANDA090756
- Marketing authorisation holder: MISSION PHARMACAL
- Status: approved
FDA — authorised 28 March 2013
- Application: NDA022556
- Marketing authorisation holder: AYTU
- Local brand name: KARBINAL ER
- Indication: SUSPENSION, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 19 December 2024
- Application: ANDA215476
- Marketing authorisation holder: LEADING
- Status: approved
Karbinal Er in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Karbinal Er approved in United States?
Yes. FDA authorised it on 19 March 2003; FDA authorised it on 7 June 2006; FDA authorised it on 27 May 2011.
Who is the marketing authorisation holder for Karbinal Er in United States?
GENUS holds the US marketing authorisation.