🇺🇸 DAPAGLIFLOZIN AND SAXAGLIPTIN MONOHYDRATE in United States

DAPAGLIFLOZIN AND SAXAGLIPTIN MONOHYDRATE (DAPAGLIFLOZIN, SAXAGLIPTIN MONOHYDRATE) regulatory status in United States.

Marketing authorisations

FDA

  • Status: approved

FDA

  • Application: ANDA211532
  • Marketing authorisation holder: LUPIN LTD
  • Local brand name: DAPAGLIFLOZIN AND SAXAGLIPTIN MONOHYDRATE
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

DAPAGLIFLOZIN AND SAXAGLIPTIN MONOHYDRATE in other countries

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

Other Other approved in United States

Frequently asked questions

Is DAPAGLIFLOZIN AND SAXAGLIPTIN MONOHYDRATE approved in United States?

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

Who is the marketing authorisation holder for DAPAGLIFLOZIN AND SAXAGLIPTIN MONOHYDRATE in United States?

LUPIN LTD is the originator. The local marketing authorisation holder may differ — check the official source linked above.