FDA — authorised 9 September 2009
- Application: ANDA077461
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: NATEGLINIDE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 meglitinides in United States
FDA authorised meglitinides on 9 September 2009
Marketing authorisations
FDA — authorised 9 September 2009
- Application: ANDA077463
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: NATEGLINIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 March 2011
- Application: ANDA077462
- Marketing authorisation holder: WATSON LABS
- Local brand name: NATEGLINIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 December 2015
- Application: ANDA205055
- Marketing authorisation holder: ALVOGEN
- Local brand name: NATEGLINIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 July 2016
- Application: ANDA205248
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: NATEGLINIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 June 2018
- Application: ANDA205544
- Marketing authorisation holder: RISING
- Local brand name: NATEGLINIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 April 2019
- Application: ANDA206432
- Marketing authorisation holder: CADILA PHARMS LTD
- Local brand name: NATEGLINIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA077467
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: NATEGLINIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
meglitinides 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 meglitinides approved in United States?
Yes. FDA authorised it on 9 September 2009; FDA authorised it on 9 September 2009; FDA authorised it on 30 March 2011.
Who is the marketing authorisation holder for meglitinides in United States?
DR REDDYS LABS LTD holds the US marketing authorisation.