Drugs@FDA: FDA Approved Drug Products

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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 INJECTABLE;IV (INFUSION) Prescription None Yes Yes
ALIMTA PEMETREXED DISODIUM EQ 100MG BASE/VIAL INJECTABLE;IV (INFUSION) 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)
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 Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/11/2017 SUPPL-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
01/08/2016 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 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
11/09/2012 SUPPL-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
01/18/2013 SUPPL-42 Manufacturing (CMC) Label (PDF)
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 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
10/17/2012 SUPPL-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
03/17/2011 SUPPL-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
11/18/2011 SUPPL-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
11/18/2011 SUPPL-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
11/18/2011 SUPPL-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
07/02/2009 SUPPL-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
07/02/2009 SUPPL-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
07/02/2009 SUPPL-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
09/26/2008 SUPPL-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
09/07/2007 SUPPL-12 Labeling-Package Insert, Labeling-Container/Carton Labels 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
02/02/2007 SUPPL-6 Labeling-Container/Carton Labels, Labeling-Package Insert 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
07/28/2006 SUPPL-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
08/19/2004 SUPPL-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 Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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