Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 022504
Company: ELI LILLY AND CO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AXIRON TESTOSTERONE 30MG/1.5ML ACTUATION SOLUTION, METERED;TRANSDERMAL Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/23/2010 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022504s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022504s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022504_axiron_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022504Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/13/2017 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022504s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022504Orig1s016ltr.pdf
01/23/2017 SUPPL-15 REMS - MODIFIED - D-N-A Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022504Orig1s015ltr.pdf
10/25/2016 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022504s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022504Orig1s014ltr.pdf
02/03/2017 SUPPL-13 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022504s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022504rig1s013ltr.pdf
05/11/2015 SUPPL-12 Labeling-Medication Guide, Labeling-Package Insert, REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022504s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022504Orig1s012ltr.pdf
06/19/2014 SUPPL-11 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022504s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022504Orig1s011ltr.pdf
02/27/2014 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

05/29/2013 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/15/2014 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/22/2011 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022504s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022504s005ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022504Orig1s005.pdf
03/31/2011 SUPPL-2 REMS-Assessment, REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022504s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022504s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/13/2017 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022504s016lbl.pdf
02/03/2017 SUPPL-13 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022504s013lbl.pdf
02/03/2017 SUPPL-13 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022504s013lbl.pdf
02/03/2017 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022504s013lbl.pdf
10/25/2016 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022504s014lbl.pdf
05/11/2015 SUPPL-12 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022504s012lbl.pdf
05/11/2015 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022504s012lbl.pdf
05/11/2015 SUPPL-12 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022504s012lbl.pdf
06/19/2014 SUPPL-11 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022504s011lbl.pdf
12/22/2011 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022504s005lbl.pdf
03/31/2011 SUPPL-2 REMS-Assessment Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022504s002lbl.pdf
03/31/2011 SUPPL-2 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022504s002lbl.pdf
11/23/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022504s000lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English