🇺🇸 ULTRAM ER in United States

FDA authorised ULTRAM ER on 8 September 2005

Marketing authorisations

FDA — authorised 8 September 2005

  • Application: NDA021692
  • Marketing authorisation holder: VALEANT PHARMS
  • Local brand name: ULTRAM ER
  • Indication: TABLET, EXTENDED RELEASE — ORAL
  • Status: approved

Read official source →

FDA

  • Status: approved

ULTRAM ER 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 ULTRAM ER approved in United States?

Yes. FDA authorised it on 8 September 2005; FDA has authorised it.

Who is the marketing authorisation holder for ULTRAM ER in United States?

VALEANT PHARMS holds the US marketing authorisation.