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 از شرکت TAKEDA PHARMS USA
New Drug Application (NDA): 021842
Company: TAKEDA PHARMS USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACTOPLUS MET | METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE | 500MG;EQ 15MG BASE | TABLET;ORAL | Prescription |
AB |
Yes | No |
| ACTOPLUS MET | METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE | 850MG;EQ 15MG 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 |
|---|---|---|---|---|---|---|---|
| 08/29/2005 | ORIG-1 | Approval |
Type 4 – New Combination |
STANDARD |
Label (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021842lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/21/2017 | SUPPL-22 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021842s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021842Orig1s022ltr.pdf |
||
| 12/12/2016 | SUPPL-21 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021842s20-21lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021842Orig1s020,s021ltr.pdf |
||
| 12/12/2016 | SUPPL-20 | Efficacy-Labeling Change With Clinical Data |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021842s20-21lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021842Orig1s020,s021ltr.pdf |
||
| 08/16/2014 | SUPPL-19 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021842s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021842Orig1s019ltr.pdf |
||
| 08/15/2013 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/17/2012 | SUPPL-16 | 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-15 | Labeling-Package Insert, Labeling-Medication Guide |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021842s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021073Orig1s043s044-021842Orig1s014s015-022024Orig1s008s007-021925Orig1s010s011ltr.pdf |
||
| 08/04/2011 | SUPPL-14 | REMS-Modified |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021842s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021073Orig1s043s044-021842Orig1s014s015-022024Orig1s008s007-021925Orig1s010s011ltr.pdf |
||
| 08/06/2010 | SUPPL-12 | Labeling-Container/Carton Labels |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021842s012ltr.pdf |
|
| 10/21/2009 | SUPPL-11 | REMS-Assessment |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021842s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021842s011ltr.pdf |
||
| 05/17/2012 | SUPPL-10 | Efficacy-Labeling Change With Clinical Data |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021842s008s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021842s008,021842s010ltr.pdf |
||
| 09/14/2009 | SUPPL-9 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021842s009ltr.pdf |
|
| 05/17/2012 | SUPPL-8 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021842s008s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021842s008,021842s010ltr.pdf |
||
| 01/04/2009 | SUPPL-7 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021842s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021842s007ltr.pdf |
||
| 09/26/2007 | SUPPL-5 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021842s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021842s005ltr.pdf |
||
| 09/28/2006 | SUPPL-3 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021073s029, 021842s003LTR.pdf |
|
| 11/04/2006 | SUPPL-2 | Labeling |
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-1 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021842s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021842s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/21/2017 | SUPPL-22 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021842s022lbl.pdf | |
| 12/12/2016 | SUPPL-21 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021842s20-21lbl.pdf | |
| 12/12/2016 | SUPPL-20 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021842s20-21lbl.pdf | |
| 08/16/2014 | SUPPL-19 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021842s019lbl.pdf | |
| 05/17/2012 | SUPPL-10 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021842s008s010lbl.pdf | |
| 05/17/2012 | SUPPL-8 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021842s008s010lbl.pdf | |
| 08/04/2011 | SUPPL-15 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021842s014s015lbl.pdf | |
| 08/04/2011 | SUPPL-15 |
Labeling-Medication Guide |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021842s014s015lbl.pdf | |
| 08/04/2011 | SUPPL-14 |
REMS-Modified |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021842s014s015lbl.pdf | |
| 10/21/2009 | SUPPL-11 |
REMS-Assessment |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021842s011lbl.pdf | |
| 01/04/2009 | SUPPL-7 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021842s007lbl.pdf | |
| 09/26/2007 | SUPPL-5 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021842s005lbl.pdf | |
| 11/04/2006 | SUPPL-2 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021073s028,021842s002lbl.pdf | |
| 08/30/2006 | SUPPL-1 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021842s001lbl.pdf | |
| 08/29/2005 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021842lbl.pdf |
ACTOPLUS MET
TABLET;ORAL; 500MG;EQ 15MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACTOPLUS MET | METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE | 500MG;EQ 15MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021842 | TAKEDA PHARMS USA |
| PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE | 500MG;EQ 15MG BASE | TABLET;ORAL | Prescription | No | AB | 200823 | AUROBINDO PHARMA LTD |
| PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE | 500MG;EQ 15MG BASE | TABLET;ORAL | Prescription | No | AB | 204802 | MACLEODS PHARMS LTD |
| PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE | 500MG;EQ 15MG BASE | TABLET;ORAL | Prescription | No | AB | 091155 | TEVA PHARMS USA |
TABLET;ORAL; 850MG;EQ 15MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACTOPLUS MET | METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE | 850MG;EQ 15MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021842 | TAKEDA PHARMS USA |
| PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE | 850MG;EQ 15MG BASE | TABLET;ORAL | Prescription | No | AB | 200823 | AUROBINDO PHARMA LTD |
| PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE | 850MG;EQ 15MG BASE | TABLET;ORAL | Prescription | No | AB | 204802 | MACLEODS PHARMS LTD |
| PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE | 850MG;EQ 15MG BASE | TABLET;ORAL | Prescription | No | AB | 091155 | TEVA PHARMS USA |
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