Application Nr Approved Date Route Status External Links
ANDA091298 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Pioglitazone Tablets Are A Thiazolidinedione And An Agonist For Peroxisome Proliferator-Activated Receptor (Ppar) Gamma Indicated As An Adjunct To Diet And Exercise To Improve Glycemic Control In Adults With Type 2 Diabetes Mellitus In Multiple Clinical Settings. (1, 14) Important Limitation Of Use: – Not For Treatment Of Type 1 Diabetes Or Diabetic Ketoacidosis. (1) Monotherapy And Combination Therapy Pioglitazone Tablets Are Indicated As An Adjunct To Diet And Exercise To Improve Glycemic Control In Adults With Type 2 Diabetes Mellitus In Multiple Clinical Settings [See Clinical Studies (14)] . Important Limitation Of Use Pioglitazone Tablets Exert Its Antihyperglycemic Effect Only In The Presence Of Endogenous Insulin. Pioglitazone Tablets Should Not Be Used To Treat Type 1 Diabetes Or Diabetic Ketoacidosis, As It Would Not Be Effective In These Settings. Use Caution In Patients With Liver Disease [See Warnings And Precautions (5.3)] .

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Pioglitazone Hydrochloride PIOGLITAZONE HYDROCHLORIDE ZINC968326

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