Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 021925
Company: TAKEDA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DUETACT GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE 2MG;30MG TABLET;ORAL Prescription AB Yes Yes
DUETACT GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE 4MG;30MG TABLET;ORAL Prescription AB Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/28/2006 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021925lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021925s000LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021925_duetact_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/21/2017 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021925s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021925Orig1s017ltr.pdf
12/12/2016 SUPPL-16 Efficacy-Labeling Change With Clinical Data Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021925Orig1s016ltr.pdf
03/16/2015 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021925s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021925Orig1s015ltr.pdf
11/12/2013 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021925s006s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021925Orig1s006,s014ltr.pdf
07/22/2013 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

05/17/2012 SUPPL-12 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-11 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021925s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021073Orig1s043s044-021842Orig1s014s015-022024Orig1s008s007-021925Orig1s010s011ltr.pdf
08/04/2011 SUPPL-10 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021925s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021073Orig1s043s044-021842Orig1s014s015-022024Orig1s008s007-021925Orig1s010s011ltr.pdf
09/23/2010 SUPPL-8 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021925s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021925s008ltr.pdf
09/09/2009 SUPPL-7 REMS-Proposal, Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021925s007ltr.pdf
11/12/2013 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021925s006s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021925Orig1s006,s014ltr.pdf
01/04/2009 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021925s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021925s005ltr.pdf
09/26/2007 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021925s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021925s004ltr.pdf
10/01/2007 SUPPL-3 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021925s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021925s003ltr.pdf
09/06/2007 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021925s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021925s002ltr.pdf
02/06/2007 SUPPL-1 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021925s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021925s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/21/2017 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021925s017lbl.pdf
03/16/2015 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021925s015lbl.pdf
11/12/2013 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021925s006s014lbl.pdf
11/12/2013 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021925s006s014lbl.pdf
08/04/2011 SUPPL-11 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021925s010s011lbl.pdf
08/04/2011 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021925s010s011lbl.pdf
08/04/2011 SUPPL-10 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021925s010s011lbl.pdf
09/23/2010 SUPPL-8 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021925s008lbl.pdf
01/04/2009 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021925s005lbl.pdf
10/01/2007 SUPPL-3 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021925s003lbl.pdf
10/01/2007 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021925s003lbl.pdf
09/26/2007 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021925s004lbl.pdf
09/06/2007 SUPPL-2 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021925s002lbl.pdf
09/06/2007 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021925s002lbl.pdf
02/06/2007 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021925s001lbl.pdf
07/28/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021925lbl.pdf

DUETACT

TABLET;ORAL; 2MG;30MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DUETACT GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE 2MG;30MG TABLET;ORAL Prescription Yes AB 021925 TAKEDA PHARMS USA
PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE 2MG;30MG TABLET;ORAL Prescription No AB 201049 SANDOZ

TABLET;ORAL; 4MG;30MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DUETACT GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE 4MG;30MG TABLET;ORAL Prescription Yes AB 021925 TAKEDA PHARMS USA
PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE 4MG;30MG TABLET;ORAL Prescription No AB 201049 SANDOZ

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English