FDA
- Status: approved
🇺🇸 Empagliflozin and Linagliptin in United States
3 US adverse-event reports
Marketing authorisations
FDA
- Application: ANDA212359
- Marketing authorisation holder: MSN LABS PVT LTD
- Local brand name: EMPAGLIFLOZIN AND LINAGLIPTIN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA212264
- Marketing authorisation holder: PRINSTON PHARMA INC
- Local brand name: EMPAGLIFLOZIN AND LINAGLIPTIN
- Indication: TABLET — ORAL
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 3
Most-reported reactions
- Abnormal Loss Of Weight — 1 report (33.33%)
- Diabetic Ketoacidosis — 1 report (33.33%)
- Pancreatitis — 1 report (33.33%)
Empagliflozin and Linagliptin 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 Empagliflozin and Linagliptin approved in United States?
Yes. FDA has authorised it; FDA has authorised it; FDA has authorised it.
Who is the marketing authorisation holder for Empagliflozin and Linagliptin in United States?
Institut für Pharmakologie und Präventive Medizin is the originator. The local marketing authorisation holder may differ — check the official source linked above.