APPLICATION
ANDA202456
TYPE
ANDA
ORIGINAL APPROVAL
2013-02-13
LATEST ACTION
2018-11-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PIOGLITAZONE HYDROCHLORIDEPrescription
PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE · TABLET · ORAL
PIOGLITAZONE HYDROCHLORIDEPrescription
PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE · TABLET · ORAL
PIOGLITAZONE HYDROCHLORIDEPrescription
PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE · TABLET · ORAL
Approval history
2018-11-26Labeling · Supplement 2 · standardAP
2018-11-26Labeling · Supplement 3 · standardAP
2018-11-26Labeling · Supplement 1 · standardAP
2013-02-13UNKNOWN · OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.