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FDA ANDA · ANDA078670

PIOGLITAZONE HYDROCHLORIDE

Sponsor: AIPING PHARM INC

APPLICATION
ANDA078670
TYPE
ANDA
ORIGINAL APPROVAL
2013-02-13
LATEST ACTION
2019-01-14
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

2019-01-14Labeling · Supplement 4 · standardAP
2019-01-14Labeling · Supplement 5 · standardAP
2016-01-26Labeling · Supplement 2 · standardAP
2013-02-13OriginalAP
VIEW ON DRUGS@FDA ↗

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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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