اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
ACTOPLUS MET XR از شرکت TAKEDA PHARMS USA
New Drug Application (NDA): 022024
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 |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022024s000lbl.pdf |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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