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FDA ANDA · ANDA200044

PIOGLITAZONE HYDROCHLORIDE

Sponsor: ACCORD HLTHCARE

APPLICATION
ANDA200044
TYPE
ANDA
ORIGINAL APPROVAL
2013-02-13
LATEST ACTION
2020-09-08
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

2020-09-08Labeling · Supplement 6 · standardAP
2020-09-08Labeling · Supplement 3 · standardAP
2015-07-21Labeling · Supplement 1 · standardAP
2013-02-13UNKNOWN · OriginalAP
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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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