FDA — authorised 22 November 2000
- Application: NDA019865
- Marketing authorisation holder: LEGACY PHARMA
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 Betapace in United States
FDA authorised Betapace on 22 November 2000
Marketing authorisations
FDA — authorised 13 May 2003
- Application: ANDA075500
- Marketing authorisation holder: AIPING PHARM INC
- Indication: Labeling
- Status: approved
FDA — authorised 4 September 2014
- Application: ANDA075429
- Marketing authorisation holder: TEVA
- Indication: Labeling
- Status: approved
FDA — authorised 2 November 2018
- Application: ANDA207429
- Marketing authorisation holder: REGCON HOLDINGS
- Status: approved
FDA — authorised 30 April 2024
- Application: ANDA077616
- Marketing authorisation holder: AUROBINDO PHARMA USA
- Indication: Labeling
- Status: approved
Aurobindo Pharma USA received marketing authorization from the FDA for Betapace on April 30, 2024. Betapace is approved for labeling, but the specific indication is not reported. The marketing authorization was granted through a standard expedited pathway.
Betapace in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Betapace approved in United States?
Yes. FDA authorised it on 22 November 2000; FDA authorised it on 13 May 2003; FDA authorised it on 4 September 2014.
Who is the marketing authorisation holder for Betapace in United States?
LEGACY PHARMA holds the US marketing authorisation.