Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021073
Company: TAKEDA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACTOS PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET;ORAL Prescription AB Yes No
ACTOS PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription AB Yes No
ACTOS PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/15/1999 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21073lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21073ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/021073A_Actos.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/12/2016 SUPPL-48 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021073s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021073Orig1s048ltr.pdf
06/27/2013 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

11/12/2013 SUPPL-46 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021073s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021073Orig1s046ltr.pdf
05/17/2012 SUPPL-45 REMS-Assessment Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021073s045,021842s016,022024s009,021925s012ltr.pdf
08/04/2011 SUPPL-44 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021073s043s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021073Orig1s043s044-021842Orig1s014s015-022024Orig1s008s007-021925Orig1s010s011ltr.pdf
08/04/2011 SUPPL-43 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021073s043s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021073Orig1s043s044-021842Orig1s014s015-022024Orig1s008s007-021925Orig1s010s011ltr.pdf
07/29/2010 SUPPL-40 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021073s040ltr.pdf
09/09/2009 SUPPL-37 REMS-Proposal, Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021073s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021073s037ltr.pdf
02/03/2011 SUPPL-35 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021073s035lbl.pdf
12/11/2008 SUPPL-34 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021073s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021073s034ltr.pdf
05/07/2008 SUPPL-33 Labeling Letter (PDF)
Patient Package Insert (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021073s033ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021073s033PI.pdf
08/14/2007 SUPPL-31 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021073s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021073s031LTR.pdf
09/06/2007 SUPPL-30 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021073s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021073s030_ltr.pdf
09/28/2006 SUPPL-29 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021073s029, 021842s003LTR.pdf
11/04/2006 SUPPL-28 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021073s028,021842s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021073S028, 021842S002ltr.pdf
08/30/2006 SUPPL-27 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021073s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021073s027ltr.pdf
02/25/2007 SUPPL-26 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021073s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021073s026ltr.pdf
07/20/2004 SUPPL-24 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21073s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21073s024ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021073_s024_ACTOS TABS.pdf
08/03/2004 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21073s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21073s023ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021073_s023_ACTOS TABS.pdf
06/11/2003 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21073slr071_actos_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21073slr071ltr.pdf
11/26/2003 SUPPL-20 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21073se8-020_actos_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21073se8-020ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021073_S020_ACTOS TABLETS_AP.pdf
12/03/2002 SUPPL-18 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21073scp018ltr.pdf
01/17/2003 SUPPL-17 Efficacy-Labeling Change With Clinical Data Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21073se8-017ltr.pdf
01/07/2002 SUPPL-16 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21073s16ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021073_S016_ACTOS.pdf
02/28/2002 SUPPL-15 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021073_S015_ACTOS_TABLETS.pdf
08/03/2001 SUPPL-14 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021073_S014_ACTOS.pdf
10/01/2002 SUPPL-13 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021073_S013_ACTOS_TABLETS.pdf
05/22/2001 SUPPL-12 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021073_S012_ACTOS TABLETS.pdf
07/02/2001 SUPPL-11 Labeling

Label is not available on this site.

07/12/2002 SUPPL-10 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21073s10lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21073se8010ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021073_S010_Actos Tablets_APPROVAL PACKAGE.pdf
07/06/2001 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

07/06/2001 SUPPL-8 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021073_S008_ACTOS TABLETS.pdf
04/25/2001 SUPPL-7 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021073_S007_ACTOS.pdf
11/03/2000 SUPPL-6 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021073_S006_ACTOS.pdf
07/26/2000 SUPPL-5 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021073_S005_ACTOS.pdf
10/25/2000 SUPPL-4 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021073_S004_ACTOS.pdf
04/11/2000 SUPPL-3 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021073_S003_ACTOS.pdf
02/25/2000 SUPPL-2 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021073_S002_ACTOS.pdf
02/25/2000 SUPPL-1 Manufacturing (CMC)-Packaging Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021073_S001_ACTOS.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/12/2016 SUPPL-48 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021073s048lbl.pdf
11/12/2013 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021073s046lbl.pdf
08/04/2011 SUPPL-44 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021073s043s044lbl.pdf
08/04/2011 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021073s043s044lbl.pdf
08/04/2011 SUPPL-43 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021073s043s044lbl.pdf
02/03/2011 SUPPL-35 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021073s035lbl.pdf
09/09/2009 SUPPL-37 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021073s037lbl.pdf
09/09/2009 SUPPL-37 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021073s037lbl.pdf
12/11/2008 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021073s034lbl.pdf
09/06/2007 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021073s030lbl.pdf
08/14/2007 SUPPL-31 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021073s031lbl.pdf
02/25/2007 SUPPL-26 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021073s026lbl.pdf
11/04/2006 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021073s028,021842s002lbl.pdf
08/30/2006 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021073s027lbl.pdf
08/03/2004 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21073s023lbl.pdf
07/20/2004 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21073s024lbl.pdf
11/26/2003 SUPPL-20 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21073se8-020_actos_lbl.pdf
06/11/2003 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21073slr071_actos_lbl.pdf
07/12/2002 SUPPL-10 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21073s10lbl.pdf
07/15/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21073lbl.pdf

ACTOS

TABLET;ORAL; EQ 15MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACTOS PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET;ORAL Prescription Yes AB 021073 TAKEDA PHARMS USA
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET;ORAL Prescription No AB 200044 ACCORD HLTHCARE
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET;ORAL Prescription No AB 200268 AUROBINDO PHARMA LTD
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET;ORAL Prescription No AB 078472 BRECKENRIDGE PHARM
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET;ORAL Prescription No AB 076798 CIPLA LTD
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET;ORAL Prescription No AB 078383 DR REDDYS LABS LTD
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET;ORAL Prescription No AB 204133 LUPIN LTD
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET;ORAL Prescription No AB 202467 MACLEODS PHARMS LTD
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET;ORAL Prescription No AB 076801 MYLAN PHARMS INC
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET;ORAL Prescription No AB 206738 PURACAP PHARM LLC
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET;ORAL Prescription No AB 078670 SANDOZ
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET;ORAL Prescription No AB 077210 TEVA PHARMS USA
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET;ORAL Prescription No AB 091298 TORRENT PHARMS LTD
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET;ORAL Prescription No AB 202456 ZYDUS PHARMS USA INC

TABLET;ORAL; EQ 30MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACTOS PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription Yes AB 021073 TAKEDA PHARMS USA
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription No AB 200044 ACCORD HLTHCARE
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription No AB 200268 AUROBINDO PHARMA LTD
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription No AB 078472 BRECKENRIDGE PHARM
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription No AB 076798 CIPLA LTD
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription No AB 078383 DR REDDYS LABS LTD
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription No AB 204133 LUPIN LTD
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription No AB 202467 MACLEODS PHARMS LTD
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription No AB 076801 MYLAN PHARMS INC
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription No AB 206738 PURACAP PHARM LLC
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription No AB 078670 SANDOZ
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription No AB 077210 TEVA PHARMS USA
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription No AB 091298 TORRENT PHARMS LTD
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription No AB 202456 ZYDUS PHARMS USA INC

TABLET;ORAL; EQ 45MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACTOS PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET;ORAL Prescription Yes AB 021073 TAKEDA PHARMS USA
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET;ORAL Prescription No AB 200044 ACCORD HLTHCARE
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET;ORAL Prescription No AB 200268 AUROBINDO PHARMA LTD
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET;ORAL Prescription No AB 078472 BRECKENRIDGE PHARM
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET;ORAL Prescription No AB 076798 CIPLA LTD
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET;ORAL Prescription No AB 078383 DR REDDYS LABS LTD
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET;ORAL Prescription No AB 204133 LUPIN LTD
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET;ORAL Prescription No AB 202467 MACLEODS PHARMS LTD
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET;ORAL Prescription No AB 076801 MYLAN PHARMS INC
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET;ORAL Prescription No AB 206738 PURACAP PHARM LLC
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET;ORAL Prescription No AB 078670 SANDOZ
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET;ORAL Prescription No AB 077210 TEVA PHARMS USA
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET;ORAL Prescription No AB 091298 TORRENT PHARMS LTD
PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET;ORAL Prescription No AB 202456 ZYDUS PHARMS USA INC

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