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
ALIMTA از شرکت LILLY
New Drug Application (NDA): 021462
Company: LILLY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALIMTA | PEMETREXED DISODIUM | EQ 500MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription |
None |
Yes | Yes |
| ALIMTA | PEMETREXED DISODIUM | EQ 100MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription |
None |
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 |
|---|---|---|---|---|---|---|---|
| 02/04/2004 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
PRIORITY; Orphan |
Label (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021462lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/30/2019 | SUPPL-53 | Efficacy-New Indication |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021462s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021462Orig1s053ltr.pdf |
||
| 04/17/2018 | SUPPL-52 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021462Orig1s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021462Orig1s052ltr.pdf |
||
| 06/04/2018 | SUPPL-51 | Efficacy-New Indication |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021462s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021462Orig1s051ltr.pdf |
||
| 10/11/2017 | SUPPL-50 | Labeling-Package Insert, Labeling-Patient Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021462s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021462Orig1s050ltr.pdf |
||
| 01/08/2016 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/11/2014 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/12/2013 | SUPPL-45 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021462s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021462Orig1s045ltr.pdf |
||
| 11/09/2012 | SUPPL-43 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021462s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021462Orig1s043ltr.pdf |
||
| 01/18/2013 | SUPPL-42 | Manufacturing (CMC) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021462s042lbl.pdf |
||
| 03/13/2013 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/04/2012 | SUPPL-40 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021462s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021462s040ltr.pdf |
||
| 10/17/2012 | SUPPL-39 | Efficacy-Labeling Change With Clinical Data |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021462s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021462Orig1s039ltr.pdf |
||
| 03/17/2011 | SUPPL-33 | Efficacy-Pediatric |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021462s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021462s033ltr.pdf |
||
| 11/18/2011 | SUPPL-32 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021462s029s030s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021462s029,s030,s032ltr.pdf |
||
| 11/18/2011 | SUPPL-30 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021462s029s030s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021462s029,s030,s032ltr.pdf |
||
| 11/18/2011 | SUPPL-29 | Efficacy-Labeling Change With Clinical Data |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021462s029s030s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021462s029,s030,s032ltr.pdf |
||
| 07/02/2009 | SUPPL-22 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021462s018s021s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021462s018,021462s021,021462s022ltr.pdf |
||
| 07/02/2009 | SUPPL-21 | Efficacy-Accelerated Approval |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021462s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021462s018,021462s021,021462s022ltr.pdf |
||
| 07/02/2009 | SUPPL-18 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021462s018s021s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021462s018,021462s021,021462s022ltr.pdf |
||
| 09/26/2008 | SUPPL-15 | Efficacy-New Indication |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021462s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021462s015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021462s015.pdf |
||
| 09/07/2007 | SUPPL-12 | Labeling-Package Insert, Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021462s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021462s012ltr.pdf |
||
| 02/02/2007 | SUPPL-6 | Labeling-Container/Carton Labels, Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021462s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021462s006ltr.pdf |
||
| 07/28/2006 | SUPPL-4 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021462s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021462s004LTR.pdf |
||
| 08/19/2004 | SUPPL-1 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021677lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21677,21462s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/30/2019 | SUPPL-53 |
Efficacy-New Indication |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021462s053lbl.pdf | |
| 06/04/2018 | SUPPL-51 |
Efficacy-New Indication |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021462s051lbl.pdf | |
| 04/17/2018 | SUPPL-52 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021462Orig1s052lbl.pdf | |
| 10/11/2017 | SUPPL-50 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021462s050lbl.pdf | |
| 10/11/2017 | SUPPL-50 |
Labeling-Patient Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021462s050lbl.pdf | |
| 09/12/2013 | SUPPL-45 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021462s045lbl.pdf | |
| 01/18/2013 | SUPPL-42 |
Manufacturing (CMC) |
Label (PDF) |
This supplement type does not usually require new labeling. |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021462s042lbl.pdf |
| 11/09/2012 | SUPPL-43 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021462s043lbl.pdf | |
| 10/17/2012 | SUPPL-39 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021462s039lbl.pdf | |
| 06/04/2012 | SUPPL-40 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021462s040lbl.pdf | |
| 11/18/2011 | SUPPL-32 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021462s029s030s032lbl.pdf | |
| 11/18/2011 | SUPPL-30 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021462s029s030s032lbl.pdf | |
| 11/18/2011 | SUPPL-29 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021462s029s030s032lbl.pdf | |
| 03/17/2011 | SUPPL-33 |
Efficacy-Pediatric |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021462s033lbl.pdf | |
| 07/02/2009 | SUPPL-22 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021462s018s021s022lbl.pdf | |
| 07/02/2009 | SUPPL-21 |
Efficacy-Accelerated Approval |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021462s021lbl.pdf | |
| 07/02/2009 | SUPPL-18 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021462s018s021s022lbl.pdf | |
| 09/26/2008 | SUPPL-15 |
Efficacy-New Indication |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021462s015lbl.pdf | |
| 09/07/2007 | SUPPL-12 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021462s012lbl.pdf | |
| 09/07/2007 | SUPPL-12 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021462s012lbl.pdf | |
| 02/02/2007 | SUPPL-6 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021462s006lbl.pdf | |
| 02/02/2007 | SUPPL-6 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021462s006lbl.pdf | |
| 07/28/2006 | SUPPL-4 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021462s004lbl.pdf | |
| 08/19/2004 | SUPPL-1 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021677lbl.pdf | |
| 02/04/2004 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021462lbl.pdf |
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