Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022307
Company: ELI LILLY AND CO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EFFIENT PRASUGREL HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription AB Yes No
EFFIENT PRASUGREL HYDROCHLORIDE EQ 10MG 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
07/10/2009 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022307s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022307s000_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022307s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022307s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/12/2016 SUPPL-14 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022307s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022307Orig1s014ltr.pdf
01/14/2016 SUPPL-13 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022307s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022307Orig1s013ltr.pdf
07/07/2015 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022307s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022307Orig1s012ltr.pdf
11/19/2013 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022307s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022307Orig1s010ltr.pdf
10/16/2013 SUPPL-8 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022307s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022307Orig1s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022307Orig1s008TOC.cfm
11/30/2012 SUPPL-7 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022307s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022307Orig1s007ltr.pdf
03/23/2012 SUPPL-6 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022307s006ltr.pdf
09/27/2011 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022307s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022307s003ltr.pdf
12/06/2010 SUPPL-2 Labeling, REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022307s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022307s002ltr.pdf
04/16/2010 SUPPL-1 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022307s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022307s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/12/2016 SUPPL-14 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022307s014lbl.pdf
01/14/2016 SUPPL-13 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022307s013lbl.pdf
07/07/2015 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022307s012lbl.pdf
11/19/2013 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022307s010lbl.pdf
10/16/2013 SUPPL-8 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022307s008lbl.pdf
11/30/2012 SUPPL-7 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022307s007lbl.pdf
09/27/2011 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022307s003lbl.pdf
12/06/2010 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022307s002lbl.pdf
12/06/2010 SUPPL-2 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022307s002lbl.pdf
04/16/2010 SUPPL-1 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022307s001lbl.pdf
07/10/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022307s000lbl.pdf

EFFIENT

TABLET;ORAL; EQ 5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EFFIENT PRASUGREL HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription Yes AB 022307 ELI LILLY AND CO
PRASUGREL PRASUGREL HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription No AB 205927 MYLAN PHARMS INC

TABLET;ORAL; EQ 10MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EFFIENT PRASUGREL HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription Yes AB 022307 ELI LILLY AND CO
PRASUGREL PRASUGREL HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 205927 MYLAN PHARMS INC

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