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FDA ANDA · ANDA204802
PIOGLITAZONE AND METFORMIN HYDROCHLORIDE
Sponsor: MACLEODS PHARMS LTD
APPLICATION
ANDA204802
TYPE
ANDA
ORIGINAL APPROVAL
2015-11-05
LATEST ACTION
2025-05-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDEPrescription
METFORMIN HYDROCHLORIDE 500MG, PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE · TABLET · ORAL
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDEPrescription
METFORMIN HYDROCHLORIDE 850MG, PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE · TABLET · ORAL
Approval history
2025-05-13Labeling · Supplement 27 · standardAP
2025-05-13Labeling · Supplement 36 · standardAP
2023-06-07Labeling · Supplement 24 · standardAP
2019-03-06Labeling · Supplement 5 · standardAP
2019-03-06Labeling · Supplement 8 · standardAP
2016-12-14Manufacturing (CMC) · Supplement 4 · unknownAP
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.
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