Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022332
Company: ELI LILLY CO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADCIRCA TADALAFIL 20MG TABLET;ORAL 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
05/22/2009 ORIG-1 Approval Type 6 - New Indication (no longer used) STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022332lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022332s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022332_adcirca_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/05/2017 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022332s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022332Orig1s009ltr.pdf
04/02/2015 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022332s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022332Orig1s007ltr.pdf
04/29/2014 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022332s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022332Orig1s006ltr.pdf
11/20/2013 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022332s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022332Orig1s005ltr.pdf
02/08/2011 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022332s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022332s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/05/2017 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022332s009lbl.pdf
04/02/2015 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022332s007lbl.pdf
04/29/2014 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022332s006lbl.pdf
11/20/2013 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022332s005lbl.pdf
02/08/2011 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022332s003lbl.pdf
05/22/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022332lbl.pdf

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