← FDA DRUG APPROVALS

FDA NDA · NDA021073

ACTOS

pioglitazone

Sponsor: TAKEDA PHARMS USA

APPLICATION
NDA021073
TYPE
NDA
ORIGINAL APPROVAL
1999-07-15
LATEST ACTION
2017-12-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ACTOS · ReferencePrescription
PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE · TABLET · ORAL
ACTOS · ReferencePrescription
PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE · TABLET · ORAL
ACTOS · ReferencePrescription
PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE · TABLET · ORAL

Approval history

2017-12-21Labeling · Supplement 49 · standardLabelAP
2016-12-12Efficacy · Supplement 48 · standardLetterAP
2013-11-12Labeling · Supplement 46 · unknownLabelAP
2013-06-27Manufacturing (CMC) · Supplement 47 · priorityAP
2012-05-17REMS · Supplement 45LetterAP
2011-08-04REMS · Supplement 43LabelAP
2011-08-04Labeling · Supplement 44 · 901 requiredLetterAP
2011-02-03Labeling · Supplement 35 · standardLabelAP
2010-07-29Labeling · Supplement 40 · standardLetterAP
2009-09-09Labeling · Supplement 37 · standardLetterAP
2008-12-11Labeling · Supplement 34 · standardLetterAP
2008-05-07Labeling · Supplement 33 · standardLetterAP
2007-09-06Labeling · Supplement 30 · standardLabelAP
2007-08-14Labeling · Supplement 31 · standardLetterAP
2007-02-25Efficacy · Supplement 26 · standardLetterAP
2006-11-04Labeling · Supplement 28 · standardLetterAP
2006-09-28Labeling · Supplement 29 · standardLetterAP
2006-08-30Labeling · Supplement 27 · standardLetterAP
2004-08-03Labeling · Supplement 23 · standardReviewAP
2004-07-20Labeling · Supplement 24 · standardReviewAP
2003-11-26Efficacy · Supplement 20 · standardReviewAP
2003-06-11Labeling · Supplement 21 · standardLabelAP
2003-01-17Efficacy · Supplement 17 · standardLetterAP
2002-12-03Manufacturing (CMC) · Supplement 18 · priorityLetterAP
2002-10-01Manufacturing (CMC) · Supplement 13 · priorityReviewAP
2002-07-12Efficacy · Supplement 10 · standardLetterAP
2002-02-28Manufacturing (CMC) · Supplement 15 · priorityReviewAP
2002-01-07Labeling · Supplement 16 · standardLetterAP
2001-08-03Manufacturing (CMC) · Supplement 14 · priorityReviewAP
2001-07-06Manufacturing (CMC) · Supplement 8 · priorityReviewAP
2001-07-06Manufacturing (CMC) · Supplement 9 · priorityAP
2001-07-02Labeling · Supplement 11 · standardAP
2001-05-22Manufacturing (CMC) · Supplement 12 · priorityReviewAP
2001-04-25Manufacturing (CMC) · Supplement 7 · priorityReviewAP
2000-11-03Manufacturing (CMC) · Supplement 6 · priorityReviewAP
2000-10-25Manufacturing (CMC) · Supplement 4 · priorityReviewAP
2000-07-26Manufacturing (CMC) · Supplement 5 · priorityReviewAP
2000-04-11Manufacturing (CMC) · Supplement 3 · priorityReviewAP
2000-02-25Manufacturing (CMC) · Supplement 2 · priorityReviewAP
2000-02-25Manufacturing (CMC) · Supplement 1 · priorityReviewAP
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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