ALIMTA از شرکت LILLY

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 NameActive IngredientsStrengthDosage Form/RouteMarketing StatusTE CodeRLDRS
ALIMTAPEMETREXED DISODIUMEQ 500MG BASE/VIALPOWDER;INTRAVENOUSPrescription

None

YesYes
ALIMTAPEMETREXED DISODIUMEQ 100MG BASE/VIALPOWDER;INTRAVENOUSPrescription

None

YesYes
Original Approvals or Tentative Approvals
Action DateSubmissionAction TypeSubmission ClassificationReview Priority; Orphan StatusLetters, Reviews, Labels, Patient Package InsertNotesUrl
02/04/2004ORIG-1 Approval

Type 1 – New Molecular Entity

PRIORITY; Orphan

Label (PDF)

Letter (PDF)

Patient Package Insert (PDF)

Review

https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021462lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21462ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021462ppilbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-462_Alimta.cfm

Supplements
Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels, Patient Package InsertNoteUrl
01/30/2019SUPPL-53 Efficacy-New Indication

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021462s053lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021462Orig1s053ltr.pdf

04/17/2018SUPPL-52 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021462Orig1s052lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021462Orig1s052ltr.pdf

06/04/2018SUPPL-51 Efficacy-New Indication

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021462s051lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021462Orig1s051ltr.pdf

10/11/2017SUPPL-50 Labeling-Package Insert, Labeling-Patient Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021462s050lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021462Orig1s050ltr.pdf

01/08/2016SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

08/11/2014SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

09/12/2013SUPPL-45 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021462s045lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021462Orig1s045ltr.pdf

11/09/2012SUPPL-43 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021462s043lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021462Orig1s043ltr.pdf

01/18/2013SUPPL-42 Manufacturing (CMC)

Label (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021462s042lbl.pdf

03/13/2013SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

06/04/2012SUPPL-40 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021462s040lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021462s040ltr.pdf

10/17/2012SUPPL-39 Efficacy-Labeling Change With Clinical Data

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021462s039lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021462Orig1s039ltr.pdf

03/17/2011SUPPL-33 Efficacy-Pediatric

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021462s033lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021462s033ltr.pdf

11/18/2011SUPPL-32 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021462s029s030s032lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021462s029,s030,s032ltr.pdf

11/18/2011SUPPL-30 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021462s029s030s032lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021462s029,s030,s032ltr.pdf

11/18/2011SUPPL-29 Efficacy-Labeling Change With Clinical Data

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021462s029s030s032lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021462s029,s030,s032ltr.pdf

07/02/2009SUPPL-22 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021462s018s021s022lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021462s018,021462s021,021462s022ltr.pdf

07/02/2009SUPPL-21 Efficacy-Accelerated Approval

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021462s021lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021462s018,021462s021,021462s022ltr.pdf

07/02/2009SUPPL-18 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021462s018s021s022lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021462s018,021462s021,021462s022ltr.pdf

09/26/2008SUPPL-15 Efficacy-New Indication

Label (PDF)

Letter (PDF)

Review (PDF)

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

09/07/2007SUPPL-12 Labeling-Container/Carton Labels, Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021462s012lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021462s012ltr.pdf

02/02/2007SUPPL-6 Labeling-Package Insert, Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021462s006lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021462s006ltr.pdf

07/28/2006SUPPL-4 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021462s004lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021462s004LTR.pdf

08/19/2004SUPPL-1 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021677lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21677,21462s001ltr.pdf

Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels,
Patient Package Insert
NoteUrl
01/30/2019SUPPL-53

Efficacy-New Indication

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021462s053lbl.pdf
06/04/2018SUPPL-51

Efficacy-New Indication

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021462s051lbl.pdf
04/17/2018SUPPL-52

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021462Orig1s052lbl.pdf
10/11/2017SUPPL-50

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021462s050lbl.pdf
10/11/2017SUPPL-50

Labeling-Patient Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021462s050lbl.pdf
09/12/2013SUPPL-45

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021462s045lbl.pdf
01/18/2013SUPPL-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
11/09/2012SUPPL-43

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021462s043lbl.pdf
10/17/2012SUPPL-39

Efficacy-Labeling Change With Clinical Data

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021462s039lbl.pdf
06/04/2012SUPPL-40

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021462s040lbl.pdf
11/18/2011SUPPL-32

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021462s029s030s032lbl.pdf
11/18/2011SUPPL-30

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021462s029s030s032lbl.pdf
11/18/2011SUPPL-29

Efficacy-Labeling Change With Clinical Data

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021462s029s030s032lbl.pdf
03/17/2011SUPPL-33

Efficacy-Pediatric

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021462s033lbl.pdf
07/02/2009SUPPL-22

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021462s018s021s022lbl.pdf
07/02/2009SUPPL-21

Efficacy-Accelerated Approval

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021462s021lbl.pdf
07/02/2009SUPPL-18

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021462s018s021s022lbl.pdf
09/26/2008SUPPL-15

Efficacy-New Indication

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021462s015lbl.pdf
09/07/2007SUPPL-12

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021462s012lbl.pdf
09/07/2007SUPPL-12

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021462s012lbl.pdf
02/02/2007SUPPL-6

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021462s006lbl.pdf
02/02/2007SUPPL-6

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021462s006lbl.pdf
07/28/2006SUPPL-4

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021462s004lbl.pdf
08/19/2004SUPPL-1

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021677lbl.pdf
02/04/2004ORIG-1 Approval

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021462lbl.pdf
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