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FDA ANDA · ANDA200823
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE
Sponsor: AUROBINDO PHARMA LTD
APPLICATION
ANDA200823
TYPE
ANDA
ORIGINAL APPROVAL
2013-02-13
LATEST ACTION
2019-02-22
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
2019-02-22Labeling · Supplement 7 · standardAP
2019-02-22Labeling · Supplement 10 · standardAP
2019-02-22Labeling · Supplement 9 · standardAP
2015-02-25Labeling · Supplement 5 · standardAP
2013-02-13Not Applicable · 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.
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