FDA — authorised 10 May 1994
- Application: ANDA074226
- Marketing authorisation holder: AUROBINDO PHARMA USA
- Local brand name: GLIPIZIDE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Comparator: glipizide in United States
FDA authorised Comparator: glipizide on 10 May 1994
Marketing authorisations
FDA — authorised 22 November 1994
- Application: ANDA074370
- Marketing authorisation holder: WATSON LABS
- Local brand name: GLIPIZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 November 1994
- Application: ANDA074378
- Marketing authorisation holder: OXFORD PHARMS
- Local brand name: GLIPIZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 February 1995
- Application: ANDA074223
- Marketing authorisation holder: WATSON LABS TEVA
- Local brand name: GLIPIZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 April 1995
- Application: ANDA074305
- Marketing authorisation holder: AIPING PHARM INC
- Local brand name: GLIPIZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 June 1995
- Application: ANDA074542
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: GLIPIZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 June 1995
- Application: ANDA074438
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: GLIPIZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 March 1996
- Application: ANDA074387
- Marketing authorisation holder: ANI PHARMS
- Local brand name: GLIPIZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 April 1997
- Application: ANDA074619
- Marketing authorisation holder: BARR LABS INC
- Local brand name: GLIPIZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 September 1997
- Application: ANDA074550
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: GLIPIZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 June 2001
- Application: ANDA075795
- Marketing authorisation holder: APOTEX
- Local brand name: GLIPIZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 October 2002
- Application: NDA021460
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Local brand name: METAGLIP
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 September 2003
- Application: ANDA076467
- Marketing authorisation holder: WATSON LABS
- Local brand name: GLIPIZIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 27 October 2005
- Application: ANDA077507
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: GLIPIZIDE AND METFORMIN HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 July 2006
- Application: ANDA077820
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: GLIPIZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 April 2007
- Application: ANDA078083
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: GLIPIZIDE AND METFORMIN HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 January 2008
- Application: ANDA077620
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: GLIPIZIDE AND METFORMIN HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 June 2010
- Application: ANDA078728
- Marketing authorisation holder: HERITAGE
- Local brand name: GLIPIZIDE AND METFORMIN HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 January 2011
- Application: ANDA078905
- Marketing authorisation holder: ZYDUS PHARMS USA INC
- Local brand name: GLIPIZIDE AND METFORMIN HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 September 2013
- Application: ANDA076159
- Marketing authorisation holder: PH HEALTH
- Local brand name: GLIPIZIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 19 May 2015
- Application: ANDA202298
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: GLIPIZIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 29 December 2016
- Application: ANDA204720
- Marketing authorisation holder: UNIQUE
- Local brand name: GLIPIZIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 12 May 2017
- Application: ANDA206928
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: GLIPIZIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 3 October 2023
- Application: ANDA214874
- Marketing authorisation holder: RUBICON RESEARCH
- Local brand name: GLIPIZIDE
- Indication: TABLET — ORAL
- Status: approved
Other Diabetes approved in United States
Frequently asked questions
Is Comparator: glipizide approved in United States?
Yes. FDA authorised it on 10 May 1994; FDA authorised it on 22 November 1994; FDA authorised it on 28 November 1994.
Who is the marketing authorisation holder for Comparator: glipizide in United States?
AUROBINDO PHARMA USA holds the US marketing authorisation.