FDA — authorised 8 May 1984
- Marketing authorisation holder: PFIZER
- Status: approved
🇺🇸 Glucotrol in United States
FDA authorised Glucotrol on 8 May 1984
Marketing authorisations
FDA — authorised 8 May 1984
- Application: NDA017783
- Marketing authorisation holder: PFIZER
- Local brand name: GLUCOTROL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 May 1994
- Application: ANDA074226
- Marketing authorisation holder: AUROBINDO PHARMA USA
- Local brand name: GLIPIZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 November 1994
- Application: ANDA074370
- Marketing authorisation holder: WATSON LABS
- 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 4 April 1997
- Application: ANDA074619
- Marketing authorisation holder: BARR LABS INC
- Local brand name: GLIPIZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 May 2000
- Application: ANDA074497
- Marketing authorisation holder: ANI PHARMS
- Indication: Labeling
- Status: approved
FDA — authorised 31 October 2000
- Application: NDA020329
- Marketing authorisation holder: PFIZER
- Indication: Manufacturing (CMC)
- 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 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 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 29 December 2016
- Application: ANDA204720
- Marketing authorisation holder: UNIQUE
- Local brand name: GLIPIZIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 4 April 2017
- Application: ANDA078728
- Marketing authorisation holder: HERITAGE
- Indication: Labeling
- Status: approved
FDA — authorised 5 April 2017
- Application: ANDA077270
- Marketing authorisation holder: TEVA PHARMS
- Indication: Labeling
- Status: approved
FDA — authorised 3 October 2023
- Application: ANDA214874
- Marketing authorisation holder: RUBICON RESEARCH
- Local brand name: GLIPIZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 March 2026
- Application: ANDA219159
- Marketing authorisation holder: GRAVITI PHARMS
- Status: approved
Glucotrol 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 Glucotrol approved in United States?
Yes. FDA authorised it on 8 May 1984; FDA authorised it on 8 May 1984; FDA authorised it on 10 May 1994.
Who is the marketing authorisation holder for Glucotrol in United States?
PFIZER holds the US marketing authorisation.