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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022504
Company: ELI LILLY AND CO

Medication Guide

REMS

Summary Review

Products on NDA 022504

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AXIRON	TESTOSTERONE	30MG/1.5ML ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION, METERED;TRANSDERMAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022504

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-Package Insert, Labeling-Medication Guide	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-Package Insert, Labeling-Medication Guide, 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

Labels for NDA 022504

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-Package Insert	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
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-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022504s012lbl.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	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

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