FDA — authorised 23 December 1964
- Application: NDA013378
- Marketing authorisation holder: LILLY
- Local brand name: DYMELOR
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Dymelor in United States
FDA authorised Dymelor on 23 December 1964
Marketing authorisations
FDA
- Status: approved
FDA
- Application: ANDA070753
- Marketing authorisation holder: USL PHARMA
- Local brand name: ACETOHEXAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070754
- Marketing authorisation holder: USL PHARMA
- Local brand name: ACETOHEXAMIDE
- Indication: TABLET — ORAL
- Status: approved
Dymelor in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Dymelor approved in United States?
Yes. FDA authorised it on 23 December 1964; FDA has authorised it; FDA has authorised it.
Who is the marketing authorisation holder for Dymelor in United States?
LILLY holds the US marketing authorisation.