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
AFINITOR از شرکت NOVARTIS
New Drug Application (NDA): 022334
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AFINITOR | EVEROLIMUS | 5MG | TABLET;ORAL | Prescription |
AB |
Yes | Yes |
| AFINITOR | EVEROLIMUS | 10MG | TABLET;ORAL | Prescription |
AB |
Yes | No |
| AFINITOR | EVEROLIMUS | 2.5MG | TABLET;ORAL | Prescription |
AB |
Yes | No |
| AFINITOR | EVEROLIMUS | 7.5MG | 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 |
|---|---|---|---|---|---|---|---|
| 03/30/2009 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
PRIORITY |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022334lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/16/2021 | SUPPL-47 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022334s047,203985s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022334Orig1s047, 203985Orig1s020ltr.pdf |
||
| 01/22/2020 | SUPPL-45 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022334s045,203985s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022334Orig1s045,203985Orig1s017ltr.pdf |
||
| 02/13/2020 | SUPPL-44 | Labeling-Package Insert, Labeling-Patient Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022334s044,203985s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022334Orig1s044, 203985Orig1s016ltr.pdf |
||
| 04/10/2018 | SUPPL-40 | Efficacy-Labeling Change With Clinical Data |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022334s040,203985s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022334Orig1s040,203985Orig1s013ltr.pdf |
||
| 09/26/2017 | SUPPL-39 | Efficacy-Labeling Change With Clinical Data |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022334s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022334Orig1s039ltr.pdf |
||
| 06/14/2016 | SUPPL-38 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022334s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022334Orig1s038ltr.pdf |
||
| 02/26/2016 | SUPPL-36 | Efficacy-New Indication |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022334s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022334Orig1s036ltr.pdf |
||
| 02/18/2016 | SUPPL-35 | Efficacy-Accelerated Approval |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022334Orig1s035ltr.pdf |
|
| 02/04/2016 | SUPPL-34 | Labeling-Package Insert, Labeling-Patient Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022334s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022334Orig1s034ltr.pdf |
||
| 01/29/2016 | SUPPL-32 | Efficacy-Accelerated Approval |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022334s032,203985s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022334Orig1s032,203985Orig1s010ltr.pdf |
||
| 09/18/2015 | SUPPL-31 | Efficacy-Labeling Change With Clinical Data |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022334s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022334Orig1s031ltr.pdf |
||
| 05/22/2015 | SUPPL-30 | Efficacy-Labeling Change With Clinical Data |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022334s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022334Orig1s030ltr.pdf |
||
| 01/23/2015 | SUPPL-29 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022334s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022334Orig1s029ltr.pdf |
||
| 10/20/2014 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/18/2014 | SUPPL-27 | Efficacy-Labeling Change With Clinical Data |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022334Orig1s027ltr.pdf |
||
| 09/12/2014 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/01/2014 | SUPPL-25 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s025203985s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022334Orig1s025,203985Orig1s007ltr.pdf |
||
| 02/20/2014 | SUPPL-24 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s021s023s024,203985s002s004s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022334Orig1s021,023,024,203985Orig1s002,004,005_replace_ltr.pdf |
||
| 02/20/2014 | SUPPL-23 | Labeling-Patient Package Insert, Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s021s023s024,203985s002s004s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022334Orig1s021,023,024,203985Orig1s002,004,005_replace_ltr.pdf |
||
| 11/06/2013 | SUPPL-22 | Efficacy-Labeling Change With Clinical Data |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022334s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022334Orig1s022,203985Orig1s003ltr.pdf |
||
| 02/20/2014 | SUPPL-21 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s021s023s024,203985s002s004s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022334Orig1s021,023,024,203985Orig1s002,004,005_replace_ltr.pdf |
||
| 06/21/2013 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/26/2013 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/29/2012 | SUPPL-18 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022334s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022334Orig1s018ltr.pdf |
||
| 04/26/2012 | SUPPL-17 | Efficacy-New Indication |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022334s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022334s017ltr.pdf |
||
| 07/20/2012 | SUPPL-16 | Efficacy-Labeling Change With Clinical Data |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022334s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022334Orig1s016ltrRepl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022334Orig1s016.pdf |
||
| 03/30/2012 | SUPPL-15 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022334s014s015.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022334s014,s015ltr.pdf |
||
| 03/30/2012 | SUPPL-14 | Efficacy-Labeling Change With Clinical Data |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022334s014s015.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022334s014,s015ltr.pdf |
||
| 05/05/2011 | SUPPL-10 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022344s9s10lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022334s009,s010ltr.pdf |
||
| 05/05/2011 | SUPPL-9 | Efficacy-New Indication |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022344s9s10lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022334s009,s010ltr.pdf |
||
| 10/29/2010 | SUPPL-6 | Efficacy-New Indication |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022334s6lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022334s006ltr.pdf |
||
| 07/09/2010 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/09/2010 | SUPPL-4 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022334s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022334s004ltr.pdf |
||
| 05/13/2010 | SUPPL-1 | Labeling-Patient Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022334s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022334s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/16/2021 | SUPPL-47 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022334s047,203985s020lbl.pdf | |
| 02/13/2020 | SUPPL-44 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022334s044,203985s016lbl.pdf | |
| 02/13/2020 | SUPPL-44 |
Labeling-Patient Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022334s044,203985s016lbl.pdf | |
| 01/22/2020 | SUPPL-45 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022334s045,203985s017lbl.pdf | |
| 04/10/2018 | SUPPL-40 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022334s040,203985s013lbl.pdf | |
| 09/26/2017 | SUPPL-39 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022334s039lbl.pdf | |
| 06/14/2016 | SUPPL-38 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022334s038lbl.pdf | |
| 02/26/2016 | SUPPL-36 |
Efficacy-New Indication |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022334s036lbl.pdf | |
| 02/04/2016 | SUPPL-34 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022334s034lbl.pdf | |
| 02/04/2016 | SUPPL-34 |
Labeling-Patient Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022334s034lbl.pdf | |
| 01/29/2016 | SUPPL-32 |
Efficacy-Accelerated Approval |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022334s032,203985s010lbl.pdf | |
| 09/18/2015 | SUPPL-31 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022334s031lbl.pdf | |
| 05/22/2015 | SUPPL-30 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022334s030lbl.pdf | |
| 01/23/2015 | SUPPL-29 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022334s029lbl.pdf | |
| 12/18/2014 | SUPPL-27 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s027lbl.pdf | |
| 07/01/2014 | SUPPL-25 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s025203985s007lbl.pdf | |
| 02/20/2014 | SUPPL-24 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s021s023s024,203985s002s004s005lbl.pdf | |
| 02/20/2014 | SUPPL-23 |
Labeling-Patient Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s021s023s024,203985s002s004s005lbl.pdf | |
| 02/20/2014 | SUPPL-23 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s021s023s024,203985s002s004s005lbl.pdf | |
| 02/20/2014 | SUPPL-21 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s021s023s024,203985s002s004s005lbl.pdf | |
| 11/06/2013 | SUPPL-22 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022334s022lbl.pdf | |
| 08/29/2012 | SUPPL-18 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022334s018lbl.pdf | |
| 07/20/2012 | SUPPL-16 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022334s016lbl.pdf | |
| 04/26/2012 | SUPPL-17 |
Efficacy-New Indication |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022334s017lbl.pdf | |
| 03/30/2012 | SUPPL-15 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022334s014s015.pdf | |
| 03/30/2012 | SUPPL-14 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022334s014s015.pdf | |
| 05/05/2011 | SUPPL-10 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022344s9s10lbl.pdf | |
| 05/05/2011 | SUPPL-9 |
Efficacy-New Indication |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022344s9s10lbl.pdf | |
| 10/29/2010 | SUPPL-6 |
Efficacy-New Indication |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022334s6lbl.pdf | |
| 07/09/2010 | SUPPL-4 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022334s004lbl.pdf | |
| 05/13/2010 | SUPPL-1 |
Labeling-Patient Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022334s001lbl.pdf | |
| 03/30/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022334lbl.pdf |
AFINITOR
TABLET;ORAL; 5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AFINITOR | EVEROLIMUS | 5MG | TABLET;ORAL | Prescription | Yes | AB | 022334 | NOVARTIS |
| EVEROLIMUS | EVEROLIMUS | 5MG | TABLET;ORAL | Prescription | No | AB | 205426 | BRECKENRIDGE |
| EVEROLIMUS | EVEROLIMUS | 5MG | TABLET;ORAL | Prescription | No | AB | 207486 | HIKMA |
| EVEROLIMUS | EVEROLIMUS | 5MG | TABLET;ORAL | Prescription | No | AB | 212936 | MYLAN |
| EVEROLIMUS | EVEROLIMUS | 5MG | TABLET;ORAL | Prescription | No | AB | 207934 | PAR PHARM |
| EVEROLIMUS | EVEROLIMUS | 5MG | TABLET;ORAL | Prescription | No | AB | 210050 | TEVA PHARMS USA |
TABLET;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AFINITOR | EVEROLIMUS | 10MG | TABLET;ORAL | Prescription | Yes | AB | 022334 | NOVARTIS |
| EVEROLIMUS | EVEROLIMUS | 10MG | TABLET;ORAL | Prescription | No | AB | 205426 | BRECKENRIDGE |
| EVEROLIMUS | EVEROLIMUS | 10MG | TABLET;ORAL | Prescription | No | AB | 207934 | PAR PHARM |
TABLET;ORAL; 2.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AFINITOR | EVEROLIMUS | 2.5MG | TABLET;ORAL | Prescription | Yes | AB | 022334 | NOVARTIS |
| EVEROLIMUS | EVEROLIMUS | 2.5MG | TABLET;ORAL | Prescription | No | AB | 205426 | BRECKENRIDGE |
| EVEROLIMUS | EVEROLIMUS | 2.5MG | TABLET;ORAL | Prescription | No | AB | 207486 | HIKMA |
| EVEROLIMUS | EVEROLIMUS | 2.5MG | TABLET;ORAL | Prescription | No | AB | 212936 | MYLAN |
| EVEROLIMUS | EVEROLIMUS | 2.5MG | TABLET;ORAL | Prescription | No | AB | 207934 | PAR PHARM |
| EVEROLIMUS | EVEROLIMUS | 2.5MG | TABLET;ORAL | Prescription | No | AB | 210050 | TEVA PHARMS USA |
TABLET;ORAL; 7.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AFINITOR | EVEROLIMUS | 7.5MG | TABLET;ORAL | Prescription | Yes | AB | 022334 | NOVARTIS |
| EVEROLIMUS | EVEROLIMUS | 7.5MG | TABLET;ORAL | Prescription | No | AB | 205426 | BRECKENRIDGE |
| EVEROLIMUS | EVEROLIMUS | 7.5MG | TABLET;ORAL | Prescription | No | AB | 207486 | HIKMA |
| EVEROLIMUS | EVEROLIMUS | 7.5MG | TABLET;ORAL | Prescription | No | AB | 212936 | MYLAN |
| EVEROLIMUS | EVEROLIMUS | 7.5MG | TABLET;ORAL | Prescription | No | AB | 207934 | PAR PHARM |
| EVEROLIMUS | EVEROLIMUS | 7.5MG | TABLET;ORAL | Prescription | No | AB | 210050 | TEVA PHARMS USA |
نظرات کاربران