🇺🇸 Januvia in United States

Januvia (Januvia) regulatory status in United States.

Marketing authorisations

FDA

  • Application: ANDA216919
  • Marketing authorisation holder: MANKIND PHARMA LTD
  • Local brand name: SITAGLIPTIN
  • Indication: TABLET — FILM COATED
  • Status: approved

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FDA

  • Application: ANDA216057
  • Marketing authorisation holder: LAURUS LABS LTD
  • Local brand name: SITAGLIPTIN
  • Indication: TABLET
  • Status: approved

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FDA

  • Application: ANDA215220
  • Marketing authorisation holder: AJANTA PHARMA LTD
  • Local brand name: SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA216086
  • Marketing authorisation holder: MSN LABORATORIES PRIVATE LTD
  • Local brand name: SITAGLIPTIN
  • Indication: TABLET — FILM COATED
  • Status: approved

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FDA

  • Application: ANDA217041
  • Marketing authorisation holder: FOSUN WANBANG (JIANGSU) PHARMACEUTICAL GROUP CO.,
  • Local brand name: SITAGLIPTIN
  • Indication: TABLET
  • Status: approved

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Other Metabolic approved in United States

Frequently asked questions

Is Januvia approved in United States?

Yes. FDA has authorised it; FDA has authorised it; FDA has authorised it.

Who is the marketing authorisation holder for Januvia in United States?

MANKIND PHARMA LTD holds the US marketing authorisation.