FDA — authorised 30 November 1995
- Marketing authorisation holder: SANOFI AVENTIS US
- Status: approved
🇺🇸 Amaryl in United States
FDA authorised Amaryl on 30 November 1995
Marketing authorisations
FDA — authorised 30 November 1995
- Application: NDA020496
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: AMARYL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 October 2005
- Application: ANDA076802
- Marketing authorisation holder: SENORES PHARMS
- Local brand name: GLIMEPIRIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 October 2005
- Application: ANDA077091
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: GLIMEPIRIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 October 2005
- Application: ANDA077366
- Marketing authorisation holder: RANBAXY
- Local brand name: GLIMEPIRIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 November 2005
- Application: ANDA077624
- Marketing authorisation holder: QUAGEN
- Local brand name: GLIMEPIRIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 December 2005
- Application: ANDA077370
- Marketing authorisation holder: PRINSTON INC
- Local brand name: GLIMEPIRIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 February 2006
- Application: ANDA077486
- Marketing authorisation holder: MYLAN
- Local brand name: GLIMEPIRIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 September 2009
- Application: ANDA077911
- Marketing authorisation holder: CARLSBAD
- Local brand name: GLIMEPIRIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 June 2012
- Application: ANDA091220
- Marketing authorisation holder: MICRO LABS
- Local brand name: GLIMEPIRIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 January 2013
- Application: ANDA201049
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 April 2013
- Application: ANDA202112
- Marketing authorisation holder: REGCON HOLDINGS
- Local brand name: GLIMEPIRIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 August 2013
- Application: ANDA078952
- Marketing authorisation holder: HIKMA PHARMS
- Local brand name: GLIMEPIRIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 August 2014
- Application: ANDA078181
- Marketing authorisation holder: ACCORD HLTHCARE
- Indication: Labeling
- Status: approved
FDA — authorised 27 December 2017
- Application: ANDA202759
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Indication: Labeling
- Status: approved
FDA
- Application: ANDA076875
- Marketing authorisation holder: RANBAXY LABS LTD
- Local brand name: GLIMEPIRIDE
- Indication: TABLET — ORAL
- Status: approved
Amaryl 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 Amaryl approved in United States?
Yes. FDA authorised it on 30 November 1995; FDA authorised it on 30 November 1995; FDA authorised it on 6 October 2005.
Who is the marketing authorisation holder for Amaryl in United States?
SANOFI AVENTIS US holds the US marketing authorisation.