FDA — authorised 6 October 2005
- Application: ANDA076802
- Marketing authorisation holder: SENORES PHARMS
- Local brand name: GLIMEPIRIDE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Stepwise add-on therapy in United States
FDA authorised Stepwise add-on therapy on 6 October 2005
Marketing authorisations
FDA — authorised 6 October 2005
- Application: ANDA077366
- Marketing authorisation holder: RANBAXY
- 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 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 28 July 2006
- Application: NDA021925
- Marketing authorisation holder: TAKEDA PHARMS USA
- Local brand name: DUETACT
- 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
- Application: ANDA076875
- Marketing authorisation holder: RANBAXY LABS LTD
- Local brand name: GLIMEPIRIDE
- Indication: TABLET — ORAL
- Status: approved
Frequently asked questions
Is Stepwise add-on therapy approved in United States?
Yes. FDA authorised it on 6 October 2005; FDA authorised it on 6 October 2005; FDA authorised it on 6 October 2005.
Who is the marketing authorisation holder for Stepwise add-on therapy in United States?
SENORES PHARMS holds the US marketing authorisation.