🇺🇸 XZP-5610 Tablet for "Part C2" in United States

FDA authorised XZP-5610 Tablet for "Part C2" on 30 September 1997

Marketing authorisations

FDA — authorised 30 September 1997

  • Application: NDA020757
  • Marketing authorisation holder: SANOFI AVENTIS US
  • Status: supplemented

FDA — authorised 30 September 1997

  • Application: NDA020758
  • Marketing authorisation holder: SANOFI AVENTIS US
  • Status: supplemented

FDA

  • Status: approved

XZP-5610 Tablet for "Part C2" in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is XZP-5610 Tablet for "Part C2" approved in United States?

Yes. FDA authorised it on 30 September 1997; FDA authorised it on 30 September 1997; FDA has authorised it.

Who is the marketing authorisation holder for XZP-5610 Tablet for "Part C2" in United States?

SANOFI AVENTIS US holds the US marketing authorisation.