🇺🇸 Alogliptin and metformin in United States

FDA authorised Alogliptin and metformin on 25 January 2013

Marketing authorisations

FDA — authorised 25 January 2013

  • Application: NDA203414
  • Marketing authorisation holder: TAKEDA PHARMS USA
  • Indication: Labeling
  • Status: approved

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FDA

  • Application: ANDA210002
  • Marketing authorisation holder: INDOCO REMEDIES
  • Local brand name: ALOGLIPTIN
  • Indication: TABLET — ORAL
  • Status: approved

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Alogliptin and metformin 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 Alogliptin and metformin approved in United States?

Yes. FDA authorised it on 25 January 2013; FDA has authorised it.

Who is the marketing authorisation holder for Alogliptin and metformin in United States?

TAKEDA PHARMS USA holds the US marketing authorisation.