FDA — authorised 28 February 1997
- Application: ANDA074767
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Status: approved
🇺🇸 Serum in United States
FDA authorised Serum on 28 February 1997
Marketing authorisations
FDA — authorised 30 July 1999
- Application: ANDA075357
- Marketing authorisation holder: L PERRIGO CO
- Status: approved
FDA
- Status: approved
Other Other approved in United States
Frequently asked questions
Is Serum approved in United States?
Yes. FDA authorised it on 28 February 1997; FDA authorised it on 30 July 1999; FDA has authorised it.
Who is the marketing authorisation holder for Serum in United States?
AUROBINDO PHARMA LTD holds the US marketing authorisation.