Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022024
Company: TAKEDA PHARMS USA
Company: TAKEDA PHARMS USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ACTOPLUS MET XR | METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE | 1GM;EQ 15MG BASE | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
ACTOPLUS MET XR | METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE | 1GM;EQ 30MG BASE | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | 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 |
---|---|---|---|---|---|---|---|
05/12/2009 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022024s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022024s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022024_actoplus_met_xr_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/21/2017 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022024s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022024Orig1s014ltr.pdf | |
12/12/2016 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022024s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022024Orig1s012,s013ltr.pdf | |
12/12/2016 | SUPPL-12 | Efficacy-Labeling Change With Clinical Data |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022024Orig1s012,s013ltr.pdf |
03/16/2015 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/27/2013 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/17/2012 | SUPPL-9 | 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-8 | REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022024s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021073Orig1s043s044-021842Orig1s014s015-022024Orig1s008s007-021925Orig1s010s011ltr.pdf | |
08/04/2011 | SUPPL-7 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022024s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021073Orig1s043s044-021842Orig1s014s015-022024Orig1s008s007-021925Orig1s010s011ltr.pdf | |
12/22/2010 | SUPPL-2 | Labeling-Medication Guide, REMS-Proposal |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022024s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022024s002ltr.pdf | |
11/12/2013 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022024s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022024Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/21/2017 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022024s014lbl.pdf | |
12/12/2016 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022024s013lbl.pdf | |
11/12/2013 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022024s001lbl.pdf | |
08/04/2011 | SUPPL-8 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022024s007s008lbl.pdf | |
08/04/2011 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022024s007s008lbl.pdf | |
08/04/2011 | SUPPL-7 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022024s007s008lbl.pdf | |
12/22/2010 | SUPPL-2 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022024s002lbl.pdf | |
12/22/2010 | SUPPL-2 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022024s002lbl.pdf | |
05/12/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022024s000lbl.pdf |