FDA — authorised 17 August 2012
- Application: ANDA076801
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: PIOGLITAZONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Pioglitazone 45 mg in United States
FDA authorised Pioglitazone 45 mg on 17 August 2012 · 14 US adverse-event reports
Marketing authorisations
FDA — authorised 26 October 2012
- Application: ANDA076798
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: PIOGLITAZONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 February 2013
- Application: ANDA202467
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: PIOGLITAZONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 February 2013
- Application: ANDA091298
- Marketing authorisation holder: TORRENT PHARMS LTD
- Local brand name: PIOGLITAZONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 February 2013
- Application: ANDA200044
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: PIOGLITAZONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 February 2013
- Application: ANDA078670
- Marketing authorisation holder: AIPING PHARM INC
- Local brand name: PIOGLITAZONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 February 2013
- Application: ANDA202456
- Marketing authorisation holder: ZYDUS PHARMS USA INC
- Local brand name: PIOGLITAZONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 February 2013
- Application: ANDA200268
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: PIOGLITAZONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 March 2013
- Application: ANDA078383
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: PIOGLITAZONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 January 2014
- Application: ANDA077210
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: PIOGLITAZONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 April 2014
- Application: ANDA204133
- Marketing authorisation holder: ANNORA PHARMA
- Local brand name: PIOGLITAZONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 October 2017
- Application: ANDA206738
- Marketing authorisation holder: PURACAP PHARM LLC
- Local brand name: PIOGLITAZONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 April 2018
- Application: ANDA207806
- Marketing authorisation holder: PRINSTON INC
- Local brand name: PIOGLITAZONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 January 2021
- Application: ANDA210165
- Marketing authorisation holder: COREPHARMA
- Local brand name: PIOGLITAZONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 14
Most-reported reactions
- Back Pain — 2 reports (14.29%)
- Gastrointestinal Infection — 2 reports (14.29%)
- Pain — 2 reports (14.29%)
- Sepsis — 2 reports (14.29%)
- Diabetes Mellitus Inadequate Control — 1 report (7.14%)
- Impaired Healing — 1 report (7.14%)
- Insomnia — 1 report (7.14%)
- Intellectual Disability — 1 report (7.14%)
- Necrotising Soft Tissue Infection — 1 report (7.14%)
- Tachypnoea — 1 report (7.14%)
Pioglitazone 45 mg in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Pioglitazone 45 mg approved in United States?
Yes. FDA authorised it on 17 August 2012; FDA authorised it on 26 October 2012; FDA authorised it on 6 February 2013.
Who is the marketing authorisation holder for Pioglitazone 45 mg in United States?
PHARMOBEDIENT holds the US marketing authorisation.