Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021454
Company: AUXILIUM PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TESTIM TESTOSTERONE 50MG/5GM PACKET GEL;TRANSDERMAL Prescription AB2 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
10/31/2002 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21454lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21454ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-454_Testim.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/30/2019 SUPPL-29 REMS - MODIFIED - D-N-A Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021454Orig1s029ltr.pdf
05/10/2019 SUPPL-27 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021454s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021454Orig1s027ltr.pdf
10/25/2016 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021454s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021454Orig1s024ltr.pdf
05/11/2015 SUPPL-23 Labeling-Package Insert, REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021454s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021454Orig1s023ltr.pdf
04/09/2015 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

06/19/2014 SUPPL-21 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021454s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021454Orig1s021ltr.pdf
05/01/2014 SUPPL-20 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021454Orig1s020ltr.pdf
01/02/2014 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

08/30/2013 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021454s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021454Orig1s016ltr.pdf
11/22/2011 SUPPL-14 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021454s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021454s014ltr.pdf
09/18/2009 SUPPL-8 Labeling, REMS-Proposal Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021454s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021454s008ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/10/2019 SUPPL-27 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021454s027lbl.pdf
05/10/2019 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021454s027lbl.pdf
10/25/2016 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021454s024lbl.pdf
05/11/2015 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021454s023lbl.pdf
05/11/2015 SUPPL-23 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021454s023lbl.pdf
06/19/2014 SUPPL-21 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021454s021lbl.pdf
08/30/2013 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021454s016lbl.pdf
11/22/2011 SUPPL-14 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021454s014lbl.pdf
09/18/2009 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021454s008lbl.pdf
09/18/2009 SUPPL-8 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021454s008lbl.pdf
10/31/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21454lbl.pdf

TESTIM

GEL;TRANSDERMAL; 50MG/5GM PACKET
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TESTIM TESTOSTERONE 50MG/5GM PACKET GEL;TRANSDERMAL Prescription Yes AB2 021454 AUXILIUM PHARMS LLC
TESTOSTERONE TESTOSTERONE 50MG/5GM PACKET GEL;TRANSDERMAL Prescription No AB2 091073 ACTAVIS LABS UT INC
VOGELXO TESTOSTERONE 50MG/5GM PACKET GEL;TRANSDERMAL Prescription No AB2 204399 UPSHER SMITH LABS

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